Does Galactooligosaccharide Enhance Nutrient Availability

Study Overview
=================
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.

Official Title
-----------------
Does Galactooligosaccharide Supplementation Enhance Nutrient Availability in Physically Active Individuals

Conditions
-----------------
Exogenous Carbohydrate Oxidation

Intervention / Treatment
-----------------
* Dietary Supplement: Bimuno Daily
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOS<br>Galactooligosaccharide consumption through the prebiotic product Bimuno. | Dietary Supplement: Bimuno Daily<br>* Galactooligosaccharide supplement within Bimuno Daily<br>|
| Placebo Comparator: Placebo<br>Maltodextrin powder | Dietary Supplement: Placebo<br>* Maltodextrin powder<br>|

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 |