Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Gut Hormone PYY
研究概览
简要总结
This study seeks to look into the effects of oligofructose supplementation on appetite, energy intake, and body weight and body composition in overweight subjects. Compared to a placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby reduce food intake moderately leading to a decrease in body weight.
详细描述
Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties.
This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host.
Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively.
It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged 20-50
- •BMI 25-35 kg/m2
- •Weight stable for three months prior to enrollment in study (weight change < 3 kg over a period of three months)
- •Habitual dietary fibre ≤ 25g/day (as assessed by 3-day dietary record)
- •Non-smokers
- •No current or history of endocrine disease, gastrointestinal disease, kidney or liver diseases, cardiovascular disease, pancreatitis, or cancer
- •Hydrogen producers
排除标准
- •Use of antibiotic less than three months prior to participation in the study
- •Participation in other research studies in the previous three months
- •Blood donation less than three months before participation in study
- •Hypertension
- •Pregnancy or breastfeeding
- •Substance abuse
- •Vegan diet
- •Regular use of prebiotic, probiotic or symbiotic food items/ supplements
- •Intense exercise undertaken for more than 5h per week
- •Metallic or electronic implants e.g. pacemaker, cochlear ear implants, fixed dental braces
- •Claustrophobia
- •Depression
结局指标
主要结局
Gut Hormone PYY
时间窗: baseline (Day 0) and post-supplementation (Day 56)
Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
Subjective Appetite Ratings in Fullness Compared to Baseline
时间窗: Baseline, 56 days
Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days
Body Weight
时间窗: Baseline, 56 days
Subjective Appetite Ratings in Hunger Compared to Baseline
时间窗: Baseline, 56 days
Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days
Energy Intake
时间窗: Baseline, 56 days
Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software. The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data).
次要结局
- Glycemic Response(baseline (Day 0) and post-supplementation (Day 56))
- Breath Hydrogen Levels(baseline (Day 0) and post-supplementation (Day 56))
- Plasma Short-chain Fatty Acids Concentrations After Treatment(Baseline, 56 days)
- Imaging of Total Adipose Tissue(Baseline, 56 days)
- Inflammatory Markers(baseline (Day 0) and post-supplementation (Day 56))
- Serum Insulin(baseline (Day 0) and post-supplementation (Day 56))
- Body Composition(Baseline, 56 days)