Does Galactooligosaccharide Enhance Nutrient Availability
- Conditions
- Exogenous Carbohydrate Oxidation
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Bimuno Daily
- Registration Number
- NCT05742516
- Lead Sponsor
- University of Bath
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Maltodextrin powder GOS Bimuno Daily Galactooligosaccharide consumption through the prebiotic product Bimuno.
- Primary Outcome Measures
Name Time Method Exogenous carbohydrate oxidation rate 120 minutes amount of ingested carbohydrate used for energy within the body. measures in grams per minute and is calculated from breath samples
- Secondary Outcome Measures
Name Time Method Whole-body fat oxidation rate 120 minutes measured from breath samples. unit is grams per minute
Plasma NEFA concentrations 120 minutes measured from blood samples in micromoles per litre
Blood lactate concentrations 120 minutes measured from blood samples in millimoles per litre
Plasma zinc concentration 28 days measured from blood samples. unit is micrograms per decilitre
Plasma ferritin concentration 28 days measured from blood samples. unit is micrograms per litre
Plasma vitamin B1 concentration 28 days measured from blood samples. unit is micrograms per decilitre
Haemoglobin concentration 120 minutes measured from blood samples. grams per decilitre
Haematocrit 120 minutes measured from blood samples. unit is percentage of red blood cells in blood
Plasma intestinal fatty acid binding protein concentration 120 minutes measured from blood samples. unit is nanograms per microlitre
Subjective scale: Gas 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Endogenous carbohydrate oxidation rate 120 minutes measured from breath samples. unit is grams per minute
Whole-body carbohydrate oxidation rate 120 minutes measured from breath samples. unit is grams per minute
Blood glucose concentrations 120 minutes measured from blood samples in millimoles per litre
Plasma insulin concentrations 120 minutes measured from blood samples in picomoles per litre
Urinary calcium/creatinine ratio 28 days measured from urine sample - ratio of milligrams per decilitre of calcium to milligrams per decilitre
Plasma vitamin B6 concentration 28 days measured from blood samples. unit is micrograms per litre
Plasma vitamin E concentration 28 days measured from blood samples. unit is micrograms per millilitre
Subjective scale: Regurgitation 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Nausea 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Urge to Defecate 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Thermal Sensation 120 minutes -4 to +4 scale. -4 very cold, 0 neutral, +4 very hot
Plasma 25-hydroxyvitamin D concentration 28 days measured from blood samples. unit is nanomoles per litre
Plasma vitamin C concentration 28 days measured from blood samples. unit is micromoles per litre
Subjective scale: Fullness 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Thermal Comfort 120 minutes -4 to +4 scale. -4 very uncomfortable, 0 just comfortable, +4 very comfortable
Subjective scale: Cramps 120 minutes 0-10 scale (0- no discomfort, 10- very severe discomfort)
Rating of Perceived Exertion 120 minutes Borg scale: 6-20. 6- very light, 20- extremely hard
Skin temperature 120 minutes measured via four temperature sensors. locations: chest, bicep, quadricep and gastrocnemius
Core temperature 120 minutes measured via rectal probe
Heart rate 120 minutes measured via polar heart rate device placed on chest via strap
Trial Locations
- Locations (1)
University of Bath
🇬🇧Bath, Bath And NE Somerset, United Kingdom
University of Bath🇬🇧Bath, Bath And NE Somerset, United KingdomAdam CollinsContact07710611694ac3413@bath.ac.ukAdam Collins Collins, MScPrincipal InvestigatorJavier Gonzalez, PhDPrincipal Investigator