Clinical trial NCT03844152: RIGHTWHEY - Responders In Gut HealTh Markers Using Fermented WHEY
Official title: Investigating the Effect of Fermented Whey Concentrate on Gut Microbial Activity: Does Butyrate Matter?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Health, Subjective
Healthy
Microbial Colonization
Keywords: fermented whey
microbiota
gut health
butyrate
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: A. Vogel
First posted: 2019-02-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stratified single arm study
Primary purpose: OTHER

Brief summary: This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals.

This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health.

Detailed description: The 8-week dietary supplementation trial will investigate the action of exogenous lactic acid consumption on the activity (using short-chain fatty acid) and composition of the gut microbiota.

Participants will be stratified according to their baseline faecal butyrate levels. Therefore volunteers will be asked to provide two faecal samples one week apart. Based on the average absolute level of butyrate in the faecal samples, volunteers will be stratified into either low, moderate or high baseline butyrate levels (detailed in table 1 below). The levels for faecal butyrate for each group are set based on a meta-analysis of 9 human studies of healthy volunteers carried out at the Rowett Institute (n=116; LaBouyer et al, 2016, unpublished). Thresholds were derived from the boundaries of tertiles. Therefore, the moderate butyrate producers represent the middle 33% (see table). Each stratification arm will have a minimum of 17 study volunteers bringing the total to n=51. This has been set to ensure the completion of at least 45 volunteers. To optimise equal gender distribution amongst all study arms a minimum of 5 females and 5 males will be recruited for each arm.

Stratification Butyrate range Low ≤13 mM Moderate butyrate 13 - 20mM High butyrate ≥20mM

Primary and secondary outcomes will be analysed between the low and high butyrate producing groups as well as the overall group effect on everyone.

Eligibility criteria: Inclusion Criteria:

* i. Men and women aged 18-68 years; BMI ranging from 18-35 kg/m2; measured at the screening visit

Exclusion Criteria:

* i. smokers
* ii. subjects with: diagnosis of diabetes, pregnant, hypertension, renal, hepatic, haematological disease, coronary heart disease or any gastrointestinal disorder
* ii. unsuitable veins for blood sampling;
* iii. inability to speak, read and understand English.
* iv. Use of antibiotics within the last 3 months will automatically exclude volunteers.
* v. Vegans. Fermented whey concentrate, (FWC), is derived from milk (animal product) which excludes potential participants adhering to a vegan diet.
* vi. allergy to any of the following: cow milk, lactose, casein, whey, sucralose, acesulfame K, citric acid, potassium benzoate, fruit flavourings.

Primary outcomes:
measure: Faecal butyrate concentration - comparing upper and lower tertile of volunteers
timeFrame: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
measure: Faecal butyrate concentration - intervention group effect
timeFrame: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
measure: Microbiota composition change
timeFrame: Assessed as change between day 0 and day 56
Secondary outcomes:
measure: Gastrointestinal wellness questionnaire
timeFrame: Day 0, 7, 14, 21, 28, 35, 42, 49 and 56
measure: Glucose tolerance and insulin sensitivity
timeFrame: Measured on Day 0 and Day 56
measure: Health related quality of life questionnaire
timeFrame: scored on Day 0 and 56
measure: Small intestinal fermentation
timeFrame: measured on Days 0, 14 and 56
measure: Faecal pH
timeFrame: measured at day 0 and 56
measure: Faecal moisture content
timeFrame: measured at day 0 and 56
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: The Rowett Institute, Human Nutrition Unit
Study officials:
affiliation: University of Aberdeen
name: Alexandra M Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aberdeen
name: Karen P Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References: