Does Galactooligosaccharide Supplementation Enhance Nutrient Availability in Physically Active Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exogenous carbohydrate oxidation rate
研究概览
简要总结
Current evidence suggests that the amount of ingested carbohydrate that we can use for energy during exercise is limited by absorption levels in the gut. Thus, strategies to increase the amount of ingested carbohydrate our body can use are of great interest.
Recent evidence has shown we may be able to use more of the ingested carbohydrate during exercise when supplementing with probiotics ("good bacteria for our gut). It is currently unknown whether the food for these "good" bacteria (known as prebiotics) can induce a similar effect. Therefore, the purpose of this study is to understand if supplementation with the prebiotic Galactooligosaccharide (onwards referred to as BIMUNO®) can increase the use of ingested carbohydrate during exercise. We also aim to understand if BIMUNO® can enhance the availability of other nutrients, such as vitamins and minerals.
Participant will attend 8 laboratory sessions at the University of Bath. The first session is a screening visit lasting no more than 30 minutes. This can take place online, over the phone, or in-person, and the remaining 7 sessions will take place in a University of Bath laboratory. The next session is preliminary testing and familiarisation (approx. 2-2.5 hours). The remaining 6 visits (4 exercise trials & 2 baseline sample collection visits) will be split across 3 main blocks of the study, each lasting 28 days. Following preliminary testing, you will be randomised into supplementing with either BIMUNO®, or placebo. Block 1 will then begin with you attending the laboratory for a baseline sample collection visit, after which you will begin supplementation for the next 28 days. After this 28-day period, you will complete two exercise trials (details below). The ambient temperature in these trials (separated by >3 days) will differ (20 & 35˚C) and will occur in a random order. The second block (termed the 'washout' period) will be a 28-day period where you will take neither BIMUNO® nor the placebo. The third block will then commence and will be identical to block 1 - the only difference being you will take the alternative supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Regular exerciser - defined as participating in at least 30 mins of structured exercise at least 3 times per week
- •Able to complete two hours of moderate intensity cycling
- •Aged 18-60 years
排除标准
- •Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir). Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.
- •Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry.
- •Following diets likely to affect study outcomes: e.g. low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets (GOS is derived from cow's milk).
- •Changes in diet, supplement use or medication likely to affect study outcomes within 2 months prior to study entry or planned during the study.
研究组 & 干预措施
GOS
Galactooligosaccharide consumption through the prebiotic product Bimuno.
干预措施: Bimuno Daily (Dietary Supplement)
Placebo
Maltodextrin powder
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Exogenous carbohydrate oxidation rate
时间窗: 120 minutes
amount of ingested carbohydrate used for energy within the body. measures in grams per minute and is calculated from breath samples
次要结局
- Subjective scale: Cramps(120 minutes)
- Core temperature(120 minutes)
- Whole-body fat oxidation rate(120 minutes)
- Plasma NEFA concentrations(120 minutes)
- Blood lactate concentrations(120 minutes)
- Plasma zinc concentration(28 days)
- Plasma ferritin concentration(28 days)
- Plasma vitamin B1 concentration(28 days)
- Haemoglobin concentration(120 minutes)
- Haematocrit(120 minutes)
- Plasma intestinal fatty acid binding protein concentration(120 minutes)
- Subjective scale: Gas(120 minutes)
- Whole-body carbohydrate oxidation rate(120 minutes)
- Blood glucose concentrations(120 minutes)
- Endogenous carbohydrate oxidation rate(120 minutes)
- Plasma insulin concentrations(120 minutes)
- Urinary calcium/creatinine ratio(28 days)
- Plasma vitamin B6 concentration(28 days)
- Plasma vitamin E concentration(28 days)
- Subjective scale: Regurgitation(120 minutes)
- Subjective scale: Nausea(120 minutes)
- Subjective scale: Urge to Defecate(120 minutes)
- Thermal Sensation(120 minutes)
- Plasma 25-hydroxyvitamin D concentration(28 days)
- Plasma vitamin C concentration(28 days)
- Subjective scale: Fullness(120 minutes)
- Thermal Comfort(120 minutes)
- Rating of Perceived Exertion(120 minutes)
- Skin temperature(120 minutes)
- Heart rate(120 minutes)
研究者
Adam Collins
Postgraduate Research Student
University of Bath