Randomized Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Functional Gummies With Polydextrose Versus Placebo for Weight Control in Adults With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
Overweight and obesity are common conditions that increase the risk of metabolic and cardiovascular diseases. Polydextrose is a type of dietary fiber that may help increase feelings of fullness by influencing natural hormones involved in appetite regulation. It may also improve postprandial glycemic responses and modulate the gut microbiota. However, evidence for its effectiveness in weight management remains limited.
The purpose of this study is to evaluate the efficacy and safety of functional gummies containing polydextrose compared with placebo for weight management in adults with overweight or obesity. Participants will be randomly assigned to receive either polydextrose or placebo gummies for 24 weeks, together with standardized dietary and physical activity recommendations.
The primary objective is to compare the percentage change in body weight over 24 weeks between participants receiving polydextrose gummies and those receiving placebo. The study will also evaluate appetite and satiety, body composition, waist circumference, metabolic parameters, quality of life, gastrointestinal symptoms, and the safety and tolerability of the study product.
The study hypothesis is that daily intake of polydextrose gummies for 24 weeks will lead to a greater reduction in body weight than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.
详细描述
Overweight and obesity are major public health challenges associated with an increased risk of type 2 diabetes, cardiovascular disease, metabolic dysfunction, and reduced quality of life. In this context, dietary and lifestyle interventions represent a first-line strategy for the management of overweight and the prevention of associated comorbidities, as they can induce favorable metabolic changes and improvements in vascular risk factors even when weight loss is modest. Within this framework, modulation of appetite and energy intake through functional ingredients such as dietary fibers has gained particular interest.
Polydextrose is a soluble, partially fermentable dietary fiber that resists digestion in the upper gastrointestinal tract and undergoes partial fermentation by the colonic microbiota. Proposed mechanisms of action include delayed gastric emptying, stimulation of satiety-related gut hormones such as glucagon-like peptide-1 (GLP-1), modulation of postprandial glycemic responses, and favorable effects on gut microbiota composition. However, evidence for its effectiveness in weight management is still limited and inconsistent, and further research is needed to confirm its clinical benefits.
This study is a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Adult participants with overweight or class I-II obesity will be randomly assigned to receive either functional gummies containing polydextrose or matching placebo gummies for 24 weeks. Randomization will be performed using a block randomization procedure stratified by age, sex, and body mass index (BMI). Participants, investigators, and study personnel involved in clinical assessment will remain blinded to treatment allocation throughout the study.
Both study groups will receive the same standardized lifestyle recommendations, including dietary counseling based on healthy Mediterranean dietary principles and guidance to maintain habitual physical activity throughout the intervention period. Participants will also receive specific instructions to avoid consuming additional foods containing polydextrose outside the study products in order to minimize potential confounding and maintain treatment blinding. Compliance will be reinforced throughout follow-up using participant diaries, structured interviews, and product accountability procedures.
Study gummies will be consumed approximately 15 to 30 minutes before each main meal (breakfast, lunch, and dinner), and the daily dose will be gradually increased during the first weeks according to gastrointestinal tolerability, up to a maximum of three gummies before each meal in participants with good tolerability.
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)
盲法说明
This is a randomized, double-blind, placebo-controlled study. Individual unblinding will only be permitted when knowledge of the assigned treatment is essential for the clinical assessment or medical management of a serious adverse event or a suspected unexpected serious adverse reaction, as specified in the study protocol.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years.
- •Body mass index (BMI) between 25 and 39.9 kg/m² (overweight or obesity class I-II).
- •Stable body weight (no change greater than 3%) in the 3 months before joining the study.
- •Usually eat at least 2 meals per day.
- •Able and willing to follow the study procedures for 24 weeks, attend all scheduled visits, and complete the required records.
- •Willing and able to sign the informed consent form.
排除标准
- •Type 2 diabetes with glycated hemoglobin (HbA1c) greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections.
- •Treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors for diabetes, heart failure, or chronic kidney disease.
- •Uncontrolled thyroid disease [thyroid-stimulating hormone (TSH) outside the normal range] or recent changes in thyroid medication in the last 3 months.
- •Significant gastrointestinal disease (such as severe irritable bowel syndrome, Crohn's disease, or ulcerative colitis).
- •History of bariatric surgery.
- •Liver cirrhosis.
- •Advanced chronic kidney disease (stage IV-V).
- •Following a very low-calorie diet (less than 800 kcal/day).
- •Alcohol dependence or heavy alcohol use that, in the investigator's opinion, could affect the study.
- •Current or recent eating disorder.
- •Planning to start or recently started a specific weight-loss diet different from the one recommended by the study endocrinology service.
- •Currently taking or having taken in the last 3 months medicines that affect appetite or body weight (such as anorectic drugs, GLP-1 receptor agonists, chronic corticosteroids, antipsychotics, or fiber supplements).
- •Pregnancy or breastfeeding.
- •Women of childbearing potential who are trying to become pregnant or plan to become pregnant during the study.
- •Known allergy or intolerance to any ingredient of the study gummies.
- •History of severe gastrointestinal problems with fermentable fibers.
研究组 & 干预措施
Placebo Gummies Group
Participants will receive matching placebo gummies without polidextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.
干预措施: Placebo Gummies (Dietary Supplement)
Polydextrose Gummies Group
Participants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.
干预措施: Polydextrose Gummies (Dietary Supplement)
结局指标
主要结局
Body Weight
时间窗: Baseline and Week 24
Percentage change in total body weight from baseline to week 24, calculated as \[(weight at week 24 - baseline weight) / baseline weight\] × 100. Body weight will be measured in kilograms using a calibrated scale under standardized conditions. Negative values indicate weight loss, whereas positive values indicate weight gain.
次要结局
- Subjective Appetite and Satiety Scores(Baseline and weeks 4, 12, and 24)
- Fat Mass(Baseline and week 24)
- Lean Body Mass(Baseline and Week 24)
- Body Mass Index (BMI)(Baseline and week 24)
- Waist Circumference(Baseline, week 12, and week 24)
- Plasma Glucose(Baseline, week 12, and week 24)
- Glycated Hemoglobin (HbA1c)(Baseline, week 12, and week 24)
- Fasting Insulin(Baseline, week 12, and week 24)
- Lipid Profile(Baseline, week 12, and week 24)
- Liver Enzymes(Baseline, week 12, and week 24)
- Systolic and Diastolic Blood Pressure(Baseline, week 12, and week 24)
- Quality of Life Scores(Baseline and week 24)
- Gastrointestinal Symptoms Scores(Baseline, week 4, week 12, and week 24)