Does Galactooligosaccharide Enhance Nutrient Availability

Does Galactooligosaccharide Supplementation Enhance Nutrient Availability in Physically Active Individuals

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.

Study Overview

• Status: Recruiting
• Conditions: Exogenous Carbohydrate Oxidation
• Intervention / Treatment: Dietary supplement: Bimuno Daily; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam J Collins; Phone Number: 07710611694; Email: ac3413@bath.ac.uk
• Study Contact Backup: Name: Javier T Gonzalez; Phone Number: 01225385518; Email: jg833@bath.ac.uk

Study Locations

• United Kingdom
  • Bath And NE Somerset
    • Bath, Bath And NE Somerset, United Kingdom, BA2 7AY
      • Recruiting
      • University of Bath
      • Contact: Adam Collins; Phone Number: 07710611694; Email: ac3413@bath.ac.uk
      • Principal Investigator: Adam Collins Collins, MSc
      • Principal Investigator: Javier Gonzalez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOS; Galactooligosaccharide consumption through the prebiotic product Bimuno.	Dietary supplement: Bimuno Daily; Galactooligosaccharide supplement within Bimuno Daily
Placebo Comparator: Placebo; Maltodextrin powder	Dietary supplement: Placebo; Maltodextrin powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exogenous carbohydrate oxidation rate	amount of ingested carbohydrate used for energy within the body. measures in grams per minute and is calculated from breath samples	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-body carbohydrate oxidation rate	measured from breath samples. unit is grams per minute	120 minutes
Whole-body fat oxidation rate	measured from breath samples. unit is grams per minute	120 minutes
Endogenous carbohydrate oxidation rate	measured from breath samples. unit is grams per minute	120 minutes
Blood lactate concentrations	measured from blood samples in millimoles per litre	120 minutes
Blood glucose concentrations	measured from blood samples in millimoles per litre	120 minutes
Plasma NEFA concentrations	measured from blood samples in micromoles per litre	120 minutes
Plasma insulin concentrations	measured from blood samples in picomoles per litre	120 minutes
Urinary calcium/creatinine ratio	measured from urine sample - ratio of milligrams per decilitre of calcium to milligrams per decilitre	28 days
Plasma 25-hydroxyvitamin D concentration	measured from blood samples. unit is nanomoles per litre	28 days
Plasma zinc concentration	measured from blood samples. unit is micrograms per decilitre	28 days
Plasma ferritin concentration	measured from blood samples. unit is micrograms per litre	28 days
Plasma vitamin B1 concentration	measured from blood samples. unit is micrograms per decilitre	28 days
Plasma vitamin B6 concentration	measured from blood samples. unit is micrograms per litre	28 days
Plasma vitamin C concentration	measured from blood samples. unit is micromoles per litre	28 days
Plasma vitamin E concentration	measured from blood samples. unit is micrograms per millilitre	28 days
Haemoglobin concentration	measured from blood samples. grams per decilitre	120 minutes
Haematocrit	measured from blood samples. unit is percentage of red blood cells in blood	120 minutes
Plasma intestinal fatty acid binding protein concentration	measured from blood samples. unit is nanograms per microlitre	120 minutes
Subjective scale: Gas	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Subjective scale: Regurgitation	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Subjective scale: Nausea	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Subjective scale: Fullness	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Subjective scale: Cramps	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Subjective scale: Urge to Defecate	0-10 scale (0- no discomfort, 10- very severe discomfort)	120 minutes
Rating of Perceived Exertion	Borg scale: 6-20. 6- very light, 20- extremely hard	120 minutes
Thermal Comfort	-4 to +4 scale. -4 very uncomfortable, 0 just comfortable, +4 very comfortable	120 minutes
Thermal Sensation	-4 to +4 scale. -4 very cold, 0 neutral, +4 very hot	120 minutes
Core temperature	measured via rectal probe	120 minutes
Skin temperature	measured via four temperature sensors. locations: chest, bicep, quadricep and gastrocnemius	120 minutes
Heart rate	measured via polar heart rate device placed on chest via strap	120 minutes

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: Clasado Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 8779 (The Newcastle upon Tyne Hospitals NHS FT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No