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Does Galactooligosaccharide Enhance Nutrient Availability

Does Galactooligosaccharide Supplementation Enhance Nutrient Availability in Physically Active Individuals

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05742516
Enrollment
30
Registered
2023-02-24
Start date
2023-04-23
Completion date
2025-10-31
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exogenous Carbohydrate Oxidation

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.

Interventions

DIETARY_SUPPLEMENTBimuno Daily

Galactooligosaccharide supplement within Bimuno Daily

DIETARY_SUPPLEMENTPlacebo

Maltodextrin powder

Sponsors

Clasado Biosciences
CollaboratorUNKNOWN
University of Bath
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Exogenous carbohydrate oxidation rate120 minutesamount of ingested carbohydrate used for energy within the body. measures in grams per minute and is calculated from breath samples

Secondary

MeasureTime frameDescription
Endogenous carbohydrate oxidation rate120 minutesmeasured from breath samples. unit is grams per minute
Blood lactate concentrations120 minutesmeasured from blood samples in millimoles per litre
Blood glucose concentrations120 minutesmeasured from blood samples in millimoles per litre
Whole-body carbohydrate oxidation rate120 minutesmeasured from breath samples. unit is grams per minute
Plasma NEFA concentrations120 minutesmeasured from blood samples in micromoles per litre
Plasma insulin concentrations120 minutesmeasured from blood samples in picomoles per litre
Urinary calcium/creatinine ratio28 daysmeasured from urine sample - ratio of milligrams per decilitre of calcium to milligrams per decilitre
Plasma 25-hydroxyvitamin D concentration28 daysmeasured from blood samples. unit is nanomoles per litre
Plasma zinc concentration28 daysmeasured from blood samples. unit is micrograms per decilitre
Plasma ferritin concentration28 daysmeasured from blood samples. unit is micrograms per litre
Plasma vitamin B1 concentration28 daysmeasured from blood samples. unit is micrograms per decilitre
Plasma vitamin B6 concentration28 daysmeasured from blood samples. unit is micrograms per litre
Plasma vitamin C concentration28 daysmeasured from blood samples. unit is micromoles per litre
Plasma vitamin E concentration28 daysmeasured from blood samples. unit is micrograms per millilitre
Whole-body fat oxidation rate120 minutesmeasured from breath samples. unit is grams per minute
Haematocrit120 minutesmeasured from blood samples. unit is percentage of red blood cells in blood
Plasma intestinal fatty acid binding protein concentration120 minutesmeasured from blood samples. unit is nanograms per microlitre
Subjective scale: Gas120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Regurgitation120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Nausea120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Fullness120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Cramps120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Subjective scale: Urge to Defecate120 minutes0-10 scale (0- no discomfort, 10- very severe discomfort)
Rating of Perceived Exertion120 minutesBorg scale: 6-20. 6- very light, 20- extremely hard
Thermal Comfort120 minutes-4 to +4 scale. -4 very uncomfortable, 0 just comfortable, +4 very comfortable
Thermal Sensation120 minutes-4 to +4 scale. -4 very cold, 0 neutral, +4 very hot
Core temperature120 minutesmeasured via rectal probe
Skin temperature120 minutesmeasured via four temperature sensors. locations: chest, bicep, quadricep and gastrocnemius
Heart rate120 minutesmeasured via polar heart rate device placed on chest via strap
Haemoglobin concentration120 minutesmeasured from blood samples. grams per decilitre

Countries

United Kingdom

Contacts

Primary ContactAdam J Collins
ac3413@bath.ac.uk07710611694
Backup ContactJavier T Gonzalez
jg833@bath.ac.uk01225385518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026