Nutritional and Clinical Trial to Evaluate the Effect of a Modified Honey With Soluble Fiber and Polyphenols Consumption in Subjects With Overweight/Obesity and Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change from Baseline Satiety Hunger Assessment
研究概览
简要总结
The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y <40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols.
Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.
详细描述
The trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. This study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects.
For the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. On the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 from 18 to 65 years old.
- •Body Mass Index (BMI) ≥25 and <40 kg/m
- •Cardiovascular risk <10% to 10 years measured by REGICOR.
- •Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
- •≥ 45 years or women ≥ 55 years.
- •Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
- •HDL cholesterol: men <40 or women <
- •Triglycerides ≥ 150mg/dL and <200 mg/dL
- •LDL cholesterol ≥ 130mg/dL and < 160mg/dL
- •Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
- •Social or familiar environment that prevents from accomplishing the dietary treatment
- •Adequate cultural level and understanding for the clinical trial.
- •Signed informed consent
排除标准
- •Body Mass Index (BMI) <25 and ≥40 kg/m
- •Individuals diagnosed with Diabetes Mellitus type 1 or
- •Individuals with dyslipidemia on pharmacological treatment.
- •Individuals with hypertension on pharmacological treatment.
- •Individuals diagnosed with eating disorders.
- •Individuals fructose-intolerant.
- •Individuals with a diagnosis of celiac disease or a gluten intolerance.
- •Individuals with severe chronic diseases (hepatic, kidney, ...)
- •Individuals receiving a pharmacological treatment that modifies the lipid or glucose profile.
- •Individuals who have participated in the last 3 months in a program or clinical trial to lose weight.
- •Individuals with mental illness.
- •Smokers wanting to stop to smoke during the period that clinical trial lasts.
- •Individuals with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
- •Individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
- •Individuals with sensory problems.
- •Individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients.
- •Individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial.
- •Subjects with intense physical activity.
- •Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
- •Pregnant or breastfeeding women.
结局指标
主要结局
Change from Baseline Satiety Hunger Assessment
时间窗: Day 1, 2
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
次要结局
- Change from Baseline Lipid Metabolism Parameters(Week 1,12)
- Change from Baseline Glucose Metabolism Parameters(Day 1, 2; Week 1, 12)
- Anthropometric Parameters(Day 1, 2; Week 1, 12)
- Amount of food consumed in a "food ad libitum"(Day 1, 2)
- Total amount of food consumed in 24h(Day 1, 2; Week 1, 6, 12)
- Sensory Perception Test(Day 1, 2; Week 6, 12)
- Adverse Effects(Day 1, 2; Week 6, 12)