Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Resting metabolic rate changes from baseline to 4 weeks intervention
研究概览
简要总结
Obesity is one of the greatest causes of preventable morbidity and mortality worldwide with the main treatments requiring significant changes to lifestyle, particularly dieting and physical exercise. Glucomannan is a dietary fibre that expands in the stomach, creating the feeling of fulness, while chromium can regulate insulin response.
详细描述
The aim of this pilot study was to investigate the effect of agglomerated glucomannan, oligofructose and chromium, as part of a calorie restricted diet plan, on weight loss, satiety, satiation, mood and gut microbiome composition in a human intervention study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy female
- •aged 18-65 years
- •with a BMI between 25 and 35 kg/m2
- •not dieting within the previous four months
- •not having lost > 5% body weight in the previous year
- •not having increased physical activity levels in the past 2-4 weeks
- •intending to modify them during the study
- •able to eat most everyday foods
排除标准
- •BMI < 25 kg/m2
- •> 35 kg/m2
- •significant health problems
- •taking any medication or supplements known to affect appetite
- •weight within the past month and/or during the study
- •pregnant, planning to become pregnant or breastfeeding
- •history of anaphylaxis to food
- •known allergies or intolerance to foods and/or to the study materials or any of their stated ingredients.
- •Volunteers who were on specific food avoidance diets
- •with abnormal eating behaviour
- •receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
- •smokers and those who have recently ceased smoking
- •Volunteers who work in appetite or feeding related areas volunteers who participated in another experimental study or receipt of
研究组 & 干预措施
Glucomannan, oligofructose and chromium mixture
Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie
干预措施: agglomerated glucomannan, oligofructose and chromium mixture (Dietary Supplement)
结局指标
主要结局
Resting metabolic rate changes from baseline to 4 weeks intervention
时间窗: To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention
Resting metabolic rate (RMR) before and at the end of the 4-week intervention was determined by indirect calorimetry using the breath-by-breath system of recording (Cortex MetaLyzer 3B device).
Weight loss changes from the baseline to 4 weeks intervention
时间窗: To test, in humans, changes in body weight from the baseline to 4 weeks intervention
The body mass was measured to the nearest 0.1 kg using a digital balance scale (Seca 707, Seca Corporation, Hamburg, Germany)
Body mass index changes from the baseline to 4 weeks intervention
时间窗: To test, in humans, changes in body mass index (calculated in Kg/m^2) from the baseline to 4 weeks intervention
Body mass index was determined as weight divided by height squared (kg/m\^2)
Blood pressure changes from the baseline to 4 weeks intervention
时间窗: To test, in humans, changes in blood pressure (calculated in mm/Hg) from the baseline to 4 weeks intervention
Blood pressure was measured using a digital blood pressure monitor (Nissei, model DS-1902, Japan Precision Instruments, Inc., Gunma, Japan).
Body composition changes from baseline to 4 weeks intervention
时间窗: To test, in humans, changes in body fat percentage (calculated in %) from the baseline to 4 weeks intervention
Body fat percentage was assessed after a 12-hour water-only fast by bioelectrical impedance analysis (BIA) method, using a Tanita BC-418 MA Segmental Body Composition Analyser, which incorporates eight tactile electrodes (Tanita Corporation, Tokyo, Japan).
Waist circumference changes from baseline to 4 weeks intervention
时间窗: To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention
Waist was assessed using anthropometric tape (Seca 201, Hamburg, Germany) over light clothing to the nearest 0.1 centimetre while the subjects were in the standing position at the end of gentle expiration. The waist circumference was measured at the mid-point between the lowest rib margin and anterior superior iliac crest and hip circumference was measured at the maximum protuberance of the buttocks, and the waist-to-hip ratio was calculated by dividing waist circumference by hip circumference.
次要结局
- Hunger, mood and cravings changes from baseline to 4 weeks intervention(To test, in humans, changes in hunger, mood and cravings (questionnaire based analysis) from the baseline to 4 weeks intervention)
- DNA Gut microbiome diversity changes from baseline to 4 weeks intervention(To test, in humans, changes in the faecal microbiota composition and microbial activity of the volunteers using DNA profiling in faeces from the baseline to 4 weeks)
研究者
DR ADELE COSTABILE
PI
University of Roehampton