Effect of a Dietary Supplement (FitLine TopShape) on the Incretin Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- GLP-1 secretion
研究概览
简要总结
Obesity is a chronic condition linked to numerous health risks and affects more than one billion people worldwide. While pharmacological treatments such as incretin-based therapies are available, they may have side effects, are not suitable for all patients, and adherence can be limited. Dietary supplements that influence appetite and satiety may represent an alternative or complementary approach.
This study will evaluate whether a dietary supplement containing plant extracts stimulates the intestinal incretin response. The primary focus is the effect on glucagon-like peptide-1 (GLP-1) secretion. Secondary outcomes include dipeptidyl peptidase-4 (DPP-4), gastric inhibitory peptide (GIP), and insulin, as well as measures of appetite, satiety, food intake, and anthropometrics.
The trial is designed as a 12-week, double-blind, randomized, placebo-controlled parallel-group study in adults with overweight or obesity (BMI 25-40, age 18-50). Participants will receive either the dietary supplement or placebo. Blood samples will be collected at baseline and after 12 weeks, both fasting and following capsule intake and a standardized liquid meal. Anthropometric measurements and visual analog scales (VAS) for hunger and satiety will also be assessed.
详细描述
Obesity is a chronic disease associated with a wide range of adverse health outcomes, including type 2 diabetes mellitus, coronary heart disease, and other metabolic disorders. The global rise in obesity is driven in part by sedentary lifestyles and the widespread availability of calorie-dense foods. According to the World Health Organization, over one billion people worldwide are affected by obesity (BMI ≥ 30 kg/m²), with even more classified as overweight (BMI ≥ 25 kg/m²). This trend poses significant challenges not only to individual health but also to public health systems due to the high costs of treating obesity-related complications.
Lifestyle modification remains the cornerstone of effective weight management. For individuals with overweight but without comorbidities, the primary goal is to prevent further weight gain through increased physical activity and dietary adjustments. Evidence suggests that even modest weight loss of 5-10% can lead to clinically meaningful improvements in cardiovascular risk factors.
In this context, dietary supplements that support appetite regulation and satiety enhancement are of growing interest. Several plant extracts-including bitter melon, yerba mate, green tea, turmeric, and others-have shown potential to stimulate the secretion of glucagon-like peptide-1 (GLP-1), a gut hormone involved in satiety signaling, appetite suppression, and insulin secretion.
GLP-1 is secreted by intestinal L-cells in response to food intake and acts via GLP-1 receptors. However, native GLP-1 has a short half-life of approximately two minutes due to rapid degradation by the enzyme dipeptidyl peptidase-4 (DPP-4). Therefore, strategies that stimulate GLP-1 secretion or inhibit DPP-4 activity may enhance satiety and support weight control. While promising, current evidence is largely limited to in vitro and animal studies, and human data are lacking.
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of a commercially available dietary supplement (FitLine TopShape) on GLP-1 secretion and related metabolic parameters. The supplement contains extracts from purslane, bitter melon, dandelion, mulberry, yerba mate, and green coffee beans. Preliminary user data from an observational study (n=40) suggest that daily intake of the supplement may increase satiety and promote weight loss (mean reduction: -1.32 kg over four weeks; unpublished). In vitro assays indicate that the bioactive compounds may reduce DPP-4 activity and increase GLP-1 secretion (unpublished).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signing the consent form
- •BMI 25-40 kg/m²
- •Age 18-50 years
排除标准
- •Known allergy to ingredients in the administered substances
- •Type 1 or 2 diabetes
- •Pregnancy
- •Breastfeeding mothers
- •Acute infectious disease
- •Renal insufficiency
研究组 & 干预措施
Dietary Supplement
Participants receive a dietary supplement: Capsule preparation containing hypromellose, calcium phosphate, inulin, yeast extract (Saccharomyces cerevisiae), bitter melon extract, green coffee bean extract, white mulberry extract, purslane extract, peppermint leaf extract, dandelion extract, green mate extract, zinc gluconate, ginger extract, biotin and yellow iron oxide (E172 - capsule colouring)
干预措施: Intervention: Dietary Supplement with Plant Extracts (Dietary Supplement)
Placebo
Participants receive a capsule preparation containing hypromellose, calcium phosphate, inulin and yellow iron oxide (E172 - capsule colouring agent)
干预措施: Placebo (Other)
结局指标
主要结局
GLP-1 secretion
时间窗: 12 weeks
Taking the dietary supplement over a period of 12 weeks changes GLP-1 secretion (area under the curve (AUC) over 60 minutes) in overweight or obese subjects\* compared to the start of the study (AUC over 60 minutes).
次要结局
- Visual analog scale (VAS) to assess satiation(12 weeks)
- Intervention vs. Placebo(12 weeks)
- Liquid Meal(12 weeks)
- Liquid Meal: Intervention vs. Placebo(12 weeks)
- Body weight(12 weeks)
- Abdominal Circumference(12 weeks)
- Visual analog scale (VAS) to assess desire to eat(12 weeks)
- Visual analog scale (VAS) to assess the amount that can be eaten right now(12 weeks)
- Visual analog scale (VAS) to assess satiety(12 weeks)
- Body mass index (BMI) in kg/m²(12 weeks)
- Visual analog scale (VAS) to assess hunger(12 weeks)
- Waist to Hip Ratio(12 weeks)
- Changes in Control of Eating Questionnaire (CoEQ)(12 weeks)