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Impact of a Food Rebalancing Program Associated with Plant-Derived Food Supplements on the Biometric, Behavioral, and Biological Parameters of Obese Subjects

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2023-11-15 17:16
MDPI
PTLv2
Followers：3Columns：927

1. Introduction

The morbidity and excess mortality induced by obesity, as defined by the body mass index (BMI), are of considerable concern [1,2]. In Europe, the prevalence of overweight and obesity is 31.9% and 13.9%, respectively [3], lower than in the USA (~40% and 22%, respectively).

While general practitioners focus primarily on prevention [4], pharmaceutical companies are developing new incretins [5,6], and surgeons are applying bariatric procedures to fight morbid obesity [7,8], several companies have proposed varied empirical and sometimes controversial dietary approaches [9,10,11]. More recently, modification of the gut microbiota has shown substantial benefits in overweight and obese patients [12].

Over the last ten years, the Dietplus® program has focused on the nutritional management of obesity (30 > BMI > 35) and overweight (25 < BMI < 30) without invasive procedures. This concept is based on personalized assessment, coaching, and follow-up. Food supplements validated by Belgian and European legislations [13,14] are compiled, and diets, food products, and personalized recipes and dishes are recommended.

The literature provides poor objective evidence on the effect of nutritional programs alone or in combination with the recommended phyto-derived food supplements (PDFSs) to facilitate dietary rebalancing [15,16]. Nevertheless, the benefits of human clinical trials using PDFSs have been reported [17,18,19,20,21,22,23,24,25], including improved well-being, loss of body weight, better lipid profile, fewer osteoarticular complaints, lower blood pressure, lower glycemic levels, and reduced respiratory insufficiency and cardiovascular risk. Some of these factors are directly associated with weight control and improved cholesterol profiles [26].

This study aims to assess the morphometric, behavioral, quality of life, and biological effects of a dietary rebalancing program, including potentiation with PDFSs.

2. Materials and Methods

2.1. Study Population, Inclusion Criteria and Enrollment

One hundred and seventy obese subjects (BMI > 29) were consecutively enrolled in the Dietplus® program for a period of 12 weeks on a voluntary basis. The participants agreed to adhere to the weight-control program and participate in the clinical study, including close anthropometric, behavioral, and biological evaluation. Medical history recorded prior to the Dietplus® treatment showed that only 39% of the subjects reported no medical pathology of a metabolic nature. Meanwhile, 61% suffered from associated pathologies: treated hypertension (22), disabling osteoarticular and back pathologies (10), dyslipidemia (5), treated diabetes (4), gastroesophageal reflux (3), cardiorespiratory insufficiency (1), non-alcoholic steatohepatitis (1) (NASH), and substituted hypothyroidism unrelated to obesity (8). Several obesity-related malignant neoplasms were reported, including two surgically resected breast cancers.

Simultaneously, 30 obese control subjects were recruited voluntarily during consultations with a multidisciplinary medical team for a medical work-up. These participants did not undergo therapeutic intervention or take medication during observation. They were also assessed for motivation, morphometric, and blood variations and underwent ultrasound, cardiac workup, sleep polysomnography, gastroscopy, and preoperative radiological examinations, and preoperative assessment. Furthermore, they received information about their medical condition without any therapeutic interference. None of the controls took PDFSs, nor were dietary restrictions imposed. Due to the hazards associated with the COVID-19 pandemic and the lack of knowledge regarding the drop-out rate, the study period was extended [27].

2.2. The Dietplus® Program

After a parametric and nutritional assessments and the preventive history, the Dietplus® program implements nutritional education on a low-calorie diet, personalized coaching on an adequate way of life, and regular intake of PDFS.

The nutritional educational aspect includes oral and written training in nutrition and diet, covering the basics of a balanced diet comprising proteins, carbohydrates, and lipids. Meal collection, preparation, cooking, and presentation are then reviewed. Personalized coaches are assigned to each subject for the duration of the program. These coaches provide weekly guidance to boost motivation and alter eating and sleeping patterns. The subject commits to following the complete plan, which is re-evaluated every week in accordance with the regulations in each country (monitored by an independent subcontractor: https://www.pharmanager-development.com/ (accessed on 15 May 2023)). The weekly administration of the PDFS associations is applied in the same way for each subject. The information regarding the properties follows the PDFS Belgian regulations [28]. European and national Institutions regulating the PDFS determine which claimed properties can be mentioned.

The PDFS program is changed every week. The content and the sequence of PDFS associations are classified into 3 groups: PDFSs directly linked to weight loss, providing satiety, and reducing appetite; PDFSs and food supplements for digestion and sleep; and food plans specifically developed for their dietary properties. The latter contains organic cereals based on wheat germ and various products with a low glycemic index and a high protein content. The PDFSs provided in the global program include green tea leaf, ash leaf, fennel seed, cinnamon bark, dandelion leaf, quack grass rhizome, orthosiphon leaf, black elderberry, organic rosemary leaf, elderflower, green tea dry extract, turmeric root, dandelion leaf, nopal powder, chitosan, Ascophyllum thallus, artichoke leaf, dry extract of green mate, artichoke dry extract, cola nut, dry extract of guarana, L-carnitine, chromium chloride, marshmallow leaf, oat seed, mate dry extract, guarana seed dry extract, brewer’s yeast powder, black radish root powder, vitamin B6, chromium chloride, caffeine, fructooligosaccharides, Fucus thallus, oat grain, konjac root, griffonna seed, and a multivitamin supplement. The composition of the 9 consecutive weekly programs is detailed in the (www.gastrospace.com/nutrients/, accessed on 15 May 2023).

2.3. Exclusion Criteria, Dropout, and Protocol Discontinuation

Exclusion criteria include a previous history of bariatric surgery, insulin-dependent diabetes, inflammatory bowel disease, neuropsychiatric pathology, or corticosteroid therapy. Furthermore, opposition from the attending physician made enrollment impossible. Subjects were considered to have dropped out if they refused to continue with the study protocol or if they deviated from the Dietplus® program.

The protocol anticipated three obstacles: refusal to cope with the burdensome follow-up coaching, the demands of the study protocol (digital anamnesis, blood sampling, repeated measurements), and the prolonged impact on mobility due to the COVID-19 pandemic.

2.4. Medical and Anthropometric Evaluation

Addiction to smoking or/and alcoholism was assessed. Medication (antihypertensive drugs, non-steroid anti-inflammatory drugs, hormonal substitutes, etc.) was maintained. Anthropometric measurements included age, height (cm), weight (kg), BMI (kg/m2), waist circumference (cm) (Pointer > 88 in women and > 102 in men) [29], heart rate (2 readings), and blood pressure (mmHg). Body composition was estimated by impedancemetry with inBody®270 (inBody Co. Ltd. Gangnam-gu, Seoul, Korea) [30,31].

2.5. Biological Evaluation

All biochemical tests were performed by the same laboratory (SYNLAB Heppignies, accredited laboratory under number 85261020) and included hemoglobin, hematocrit, erythrocytes, VCM, TIBC, serum iron, hydromineral balance, blood ionogram (Na+/K+/Cl−/HCO3−), Vit D, Mg++, phosphorus, chronic inflammatory state (CRP US, orosomucoid, fibrinogen), PINI index (prognostic inflammatory and nutritional index) [32], nutritional status (total protein level, albuminemia, prealbuminemia), and renal function (urea, creatinine, uric acid). Resistance to insulin and potential diabetes was assessed by fasting blood sugar, insulinemia—homeostatic model assessment of insulin resistance (HOMA) [33], and quantitative insulin sensitivity check index (QUICKI-index) [34]. QUICKI = 1/[log(I0) + log(G0)], where I0 is the fasting insulin (μU/mL), and G0 represents the fasting glucose (mg/dL). Lipid parameters included total cholesterol, triglycerides, LDL, VLDL, non-LDL, and HDL cholesterol. Cardiovascular risk (apolipoproteins B, Apolipo A/B ratio, atherosclerotic index) and liver function (PAL, GGT) were also assessed.

2.6. Behavioral Evaluation and Monitoring

Evaluation of the psycho-affective state, motivation, determination, and affective environment was evaluated by several self-assessment scales completed online by each subject. A WHO-compliant “quality of life” scale was applied before and after the protocol. Prochaska and Di Clemente developed a scale based on multiple contradictory questions [35,36] to test the subject’s ability to change. The study focused on lifestyle changes, such as consumption habits, eating habits, physical activity, and, more generally, lifestyle changes .

The Mac Gill scale [37] validated for obese patients [38] was applied. The success of any weight control program depends on the attitude toward food, particularly the organization of meals, food preparation, and “conscientiousness” [39,40,41,42]. Indeed, obesity alters taste, and relative anosmia favors obesity [43,44]. The subjects were submitted to a 20-item nutritional questionnaire, “Nutriscore.” The score, calculated on a scale of 60, bears no relation to the one used in food chain labeling [45] .

Daily physical activity was assessed using a 15-question online questionnaire focusing on four areas of daily life: private and professional spheres, leisure, and structured sports activity . Only 74 subjects who responded to all four online questionnaires were considered for data collection.

2.7. Statistical Analysis

Statistical analysis was performed using R Statistical Software (v4.2.2; R Core Team 2022). Data were presented as median (range) or mean ± standard deviation (SD) for continuous variables according to non-normal or normal distribution (determined by the Shapiro–Wilk test), respectively. For categorical variables, data were presented as numbers (percentages), whereas continuous variables, pre- and post-treatment data were compared using a Wilcoxon signed-rank test for non-normal distributions or a Student’s t-test for paired samples with normal distribution. The threshold for statistical significance was set at p < 0.05. Effect sizes were calculated as follows: Cohen’s d (1988) for parametric tests (small effect: d ≥ 0.2; mean effect: d ≥ 0.5; large effect: d ≥ 0.8 and below 0.2 is trivial), and rank-biserial correlation for non-parametric tests.

3. Results

The program compliance of the 200 subjects is illustrated in Figure 1.

Figure 1. Study design focusing on the clinical pathways and incidence of dropout and exclusion.

3.1. Dropout: Analysis and Interpretation

The protocol interruptions in Dietplus® and control subjects are presented for both groups. Of the 30 controls, 5 did not follow the clinical itinerary, and 4 had a pathology contraindicating the continuation of the bariatric surgery protocol (neuroendocrine tumor, pregnancy, acute diverticulitis, hepatic mass). Finally, family constraints, financial issues, and a lack of compliance with the study protocol impacted one patient each.

Protocol interruptions for Dietplus® and control subjects were comparable. The investigators called back the 95 subjects excluded or lost to follow-up; 15 could not be contacted or refused to be interviewed. Meanwhile, 80 explained their failure, revealing five major causes and four more anecdotal causes.

Among Dietplus® subjects, the five main reasons for abandonment include a severe lack of compliance with the Dietplus® program (26.2%), medical exclusion criteria (15%), family constraints with the predominance of strong opposition from a life partner, financial constraints (weekly cost was estimated between 40 and 50 €) and logistical problems often related to professional constraints.

3.2. Comparison of the Two Cohorts

We sought to determine whether the profile of control patients differed from that of the Dietplus® customers. The profiles were similar in age, sex, BMI, and abdominal obesity. Nevertheless, the Dietplus® subjects dropped out more often, had fewer co-morbidities, and a lower weight-loss target (−19 kg) than the control group (−28 kg).

At the family, behavioral, and psychological levels, the two cohorts were comparable, with even alcohol consumption and smoking identical. Moreover, upon enrollment, the Dietplus® subjects had an average height of 165.1 ± 11 cm and mean weight of 94.1 ± 14.2 kg, with extremes ranging from 73 to 158 kg. Regarding abdominal obesity, the waist circumference in the 148 women was 108.4 ± 12 cm, categorized as pathological for 77 subjects.

The two cohorts were compared at the time of enrollment regarding psycho-behavioral scores . Notably, control patients were referred for medical treatment, whereas Dietplus® subjects sought a non-medical approach. While the quality of life and sporting activities were identical in both cohorts, dietary and nutritional behavior was significantly (p < 0.01) more disturbed in Dietplus® subjects, with a nutriscore of 43.5 ± 4.2% versus 59 ± 5.7%. However, the ability to change (Prochaska Di Clemente Scale) was significantly improved (p < 0.01) when the Dietplus® program was considered.

The two cohorts presented reasonably comparable profiles, with higher expectations in obese patients consulting a medical team. Eating habits were more compromised in subjects within the Dietplus® group.

3.3. Evolution of the Control Group

The slight weight gain observed in the control group expected as obese patients are more likely to seek medical attention during periods of weight regain. During the work-up and observation periods, the weight gain was 1.0 ± 0.2 kg. The results were expected given that no therapeutic action was applied in the controls. However, the medical and paramedical consultations led to “awareness” as ¼ of patients moved from the contemplation stage to the determination stage.

The 12 weeks of medical observation and communication of the results of the medical work-up did not improve quality of life, nutritional habits, or physical activity. The only observed impact of the medical work-up was positive changes in motivation.

3.4. Effect of The Dietplus® Cure

The effect of the program was measured via pre- and post-therapeutic values. Nevertheless, the comparison with the control group was useful as the natural evolution of obesity was unfavorable during the same period. For example, at the end of the Dietplus® program, subjects lost an average of 10 ± 2.2 kg compared to the control group whose overweight increased.

4. Discussion

This study exhibited a major drop-out rate in both study groups. Hence, helping obese individuals control their diet and energy expenditure remains a major challenge [46,47,48,49].

4.1. Common Clinical Problems Observed in Obese Subjects

In the control population, almost one-third of patients dropped out during the development process. In this instance, the phenomenon of medical shopping is emphasized as obese patients often consider being overweight as a cosmetic problem [50]. Such a high drop-out rate was observed in both cohorts. This underscores the difficulty in motivating changes in dietary behavior and incorporating physical activity.

The certainty of knowing one’s solution to the problem further complicates the relationship with any therapist. Moreover, the physician builds less rapport with obese patients [51]. Indeed, the weight curve during the study period exhibited a natural deterioration in the control group rather than a stable weight. However, in this group, biochemical values remained stable during the 12-week observation period.

4.2. Morphometric Parameters

Substantial weight loss was observed in the Dietplus® subjects. All measurements, in particular impedancemetry, confirmed a reduction in abdominal obesity, with positive consequences on vital parameters, namely, a decrease in heart rate, hypertension, and cardiovascular risk [52,53]. Physical indices of comorbidity risk were also clearly improved. However, this study is limited by a relatively short-term follow-up. Hence, systematic annual monitoring of the 77 subjects who had completed the protocol is underway.

4.3. Behavioral Parameters

The Dietplus® program induced positive effects on the behavior of obese subjects, with improved QOL, Nutriscore, motivation to change lifestyle, and (discrete) improvement in physical activity. The necessity of adherence to a strict protocol is confirmed [46,54].

4.4. Metabolic Parameters

Several metabolic parameters were significantly improved over the 12-week study period, certainly in relation to the average 9 kg weight loss.

5. Conclusions

Healthcare systems are facing a global overweight and obesity pandemic. While many non-invasive methods lack scientific evaluation and evidence-based support, the present study provides evidence of a clear benefit for the Dietplus® program. However, the impact of this study is limited by several constraints, including the absence of a double-blind controlled procedure and the concept of a totum program with different modes of action, excluding physical training [95]. Indeed, a substantial improvement in metabolic parameters and behavioral changes were observed that are likely to guarantee long-term weight control. Moreover, the contribution of the Dietplus® program could be considered in terms of cost-effectiveness [96] within the panel of therapeutic approaches to weight control.

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Reproduced from:https://www.mdpi.com/2072-6643/15/22/4780
Between 2021 and 2023, the Scientific Council of Dietplus®, a group specialized in overweight and obesity management, conducted a clinical study on 170 volunteer subjects with a BMI > 29 Kg/m2 consecutively recruited. The Dietplus® program comprises nutritional education, intensive, personalized coaching, and consuming food supplements rich in plant derivatives. The aim of this study was to assess the effect of the Dietplus® program on biometric, behavioral, and biological parameters. A control group of 30 obese patients was followed for a similar 12-week period. Mean weight loss reached 9 ± 2.1 kg in the Dietplus® test group versus a 1 ± 0.1 kg weight gain in the control group. Excess weight loss reached 33 ± 13%, and fat mass loss was 7.6% (p < 0.001); waist circumference was reduced by 30%. Quality of Life, Nutriscore, and Prochaska di Clemente scale significantly improved (p < 0.001). Biological parameters showed substantial improvements in the carbohydrate profile and insulin resistance (HOMA index) and in the lipid profile with lower plasma triglyceride (p < 0.01) and VLDL (p < 0.01) concentrations. Inflammatory parameters (orosomucoid, ultrasensitive C-reactive protein, and PINI indices) were also substantially reduced. These results indicate a substantial benefit in subjects who followed the Dietplus® program. (Dietplus® 116 Rue Robert Bunsen, 57460 Behren-lès-Forbach, France is active in France Belgium and Spain. Plant Derived Food Supplements are produced in France). Indeed, improvements were observed in all biometric, behavioral, and metabolic parameters.
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Type 2 diabetes mellitus (DM) is a chronic metabolic disorder posing multifaceted challenges to global public health. Among its numerous complications, infected diabetic foot ulcers (IDFUs) represent a particularly debilitating consequence. Beyond cardiovascular implications, there is an emerging understanding of the interconnectedness among IDFUs, neuropathy, atherosclerosis, and dyslipidemia. IDFUs, peripheral neuropathy, and atherosclerosis share common risk factors and mechanistic pathways. The primary objective of this study was to characterize the lipid profiles in DM patients with IDFUs, comparing them with DM patients without foot ulcers, and with a control group of healthy subjects. The secondary objectives included evaluating apolipoprotein E (ApoE) levels across these study groups and comparing lipid profiles within IDFU subgroups. A total of 160 patients were assessed for this study. After applying exclusion criteria, 140 participants were included, divided into three groups: Group IDFU (80 patients with IDFUs), Group DM (32 patients with DM but no foot ulcers), and Group Controls (28 healthy controls). Compared to Group DM, Group IDFU demonstrated lower levels of high-density lipoprotein cholesterol (HDL-C) (30.9 ± 12.6 mg/dL vs. 40.8 ± 16.6 mg/dL, p = 0.002), but improved levels of ApoE (160.9 ± 68.4 mg/dL vs. 197.2 ± 69.6 mg/dL, p = 0.01), triglycerides (TG) (126.9 ± 56.2 mg/dL vs. 165.8 ± 79.0 mg/dL, p = 0.004), low-density lipoprotein cholesterol (LDL-C) (84.2 ± 32.3 mg/dL vs. 92.3 ± 39.3 mg/dL, p = 0.1), and total cholesterol (133.6 ± 43 mg/dL vs. 164.6 ± 44.4 mg/dL, p = 0.002). The IDFU patients exhibit improved lipid profiles, excepting HDL-C, which is unusual because IDFU follows complications related to dyslipidemia for DM patients. Anemia, impaired renal function, and elevated TG levels were identified as biomarkers for mortality among patients with IDFUs. The data suggest that a lower level of HDL-C and an improved lipid profile may indicate a systemic end-stage disease manifestation in DM
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Obesity is one of the main risk factors for cardiovascular diseases, type II diabetes, hypertension, and certain cancers. Obesity in women at the reproductive stage adversely affects contraception, fertility, maternal well-being, and the health of their offspring. Being a major protein component in chylomicrons and high-density lipoproteins, apolipoprotein A-IV (apoA-IV) is involved in lipid metabolism, food intake, glucose homeostasis, prevention against atherosclerosis, and platelet aggregation. The goal of the present study is to determine the impact of apoA-IV deficiency on metabolic functions in 129X1/SvJ female mouse strain. After chronic high-fat diet feeding, apoA-IV−/− mice gained more weight with a higher fat percentage than wild-type (WT) mice, as determined by measuring their body composition. Increased adiposity and adipose cell size were also observed with a microscope, particularly in periovarian fat pads. Based on plasma lipid and adipokine assays, we found that obesity in apoA-IV−/− mice was not associated with hyperlipidemia but with higher leptin levels. Compared to WT mice, apoA-IV deficiency displayed glucose intolerance and elevated insulin levels, according to the data of the glucose tolerance test, and increased HOMA-IR values at fasting, suggesting possible insulin resistance. Lastly, we found obesity in apoA-IV−/− mice resulting from reduced energy expenditure but not food intake. Together, we established a novel and excellent female mouse model for future mechanistic study of obesity and its associated comorbidities.
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Intake of whole grain foods is associated with improving metabolic profile compared to refined grain products, but the underlying mechanism remains unclear. The present study examined the effects of brown rice (BRR) or germinated brown rice (GBR) supplementation on fecal short-chain fatty acids (SCFAs), and relationship with gut microbiota, metabolism and inflammation in high fat (HF)-diet-fed mice. The results demonstrated that an HF diet supplemented with BRR or GBR comparably increased the abundance of fecal isobutyric acid compared to that in mice receiving HF+white rice (WHR) diet (p < 0.01). The abundance of valeric acid in HF+GBR-diet-fed mice was higher than those receiving HF+WHR diet (p < 0.05). The abundances of fecal isobutyric acid negatively correlated with fasting plasma glucose, insulin, cholesterol, triglycerides, tumor necrosis factor-α, plasminogen activator inhibit-1, monocyte chemotactic protein-1 and homeostatic model assessment of insulin resistance (p < 0.01). The abundance of valeric acids negatively correlated with insulin resistance (p < 0.05). The abundances of isobutyric acid positively correlated with Lactobacillus, but negatively correlated with Dubosiella genus bacteria (p < 0.05). The findings demonstrated that the increases in SCFAs in the feces of BRR and GBR-treated mice were associated with improvements in gut microbiome, metabolic and inflammatory profile, which may contribute to the antidiabetic and anti-inflammatory effects of the whole grains in HF-diet-fed mice.
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