NCT03554525已完成3 期
Clinical Trial to Evaluate the Usefulness of the Regular Consumption of a Food Supplement(FAT-BINDER DAMM) on Weight Regain After an Interventional Diet Program on Overweight/Obese People
Instituto de Investigación Hospital Universitario La Paz2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Weight Regain
研究概览
简要总结
Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program
详细描述
- 60 participants will consume experimental product every day 3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the 12 first weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period). When PPP period is over, volunteers will continue consuming the product for 9 months more (Post-PPP period).
- 60 participants will consume everyday 3 placebo sticks (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the first 12 weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period ). When PPP period is over, volunteers will continue consuming the product for 9 months more.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ranging from 18 to 65 years old.
- •BMI ≥27 and <40 kg/m
- •Overweight type II, obesity type I and II
- •Social or familiar environment that prevents from accomplishing the dietary treatment.
- •Willingness to follow a balanced hypocaloric diet in order to lose weight and perform regular physical adapted activity.
- •Adequate cultural level and understanding of the clinical trial.
- •Signed informed consent.
排除标准
- •Individuals diagnosed with Diabetes Mellitus type I.
- •Individuals diagnosed with Diabetes Mellitus type II on pharmacological treatment.
- •Individuals with dyslipidemia on pharmacological treatment.
- •Individuals with hypertension on pharmacological treatment uncontrolled.
- •Individuals allergic to yeast.
- •Individuals with chronic diseases (hepatic, kidney...).
- •Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
- •Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs).
- •Pregnant or breastfeeding women.
结局指标
主要结局
Weight Regain
时间窗: 12 months
Change from baseline in kilograms
次要结局
- 24 hours Dietary Recall(12 months)
- Lean mass percentage(12 months)
- Fat mass percentage(12 months)
- High density lipoprotein cholesterol(12 months)
- Satiety evaluation([Just before eating the product; Just after eating; After 60 minutes; After 90 minutes] Fasting for at least 4 hours. Must do it with a snack accompanied and 500 ml water.)
- Low density lipoprotein cholesterol(12 months)
- Sensory perception(Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.)
- Body Mass Index (weight/height^2)(12 months)
- Body water percentage(12 months)
- Triglycerides(12 months)
- Fiber(12 months)
- International Physical Activity Questionnaire(12 months)
研究者
研究点 (2)
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