RIGHTWHEY - Responders In Gut HealTh Markers Using Fermented WHEY

NCT03844152 | Terminated

• 1 other identifier: 808
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Health, Subjective; Healthy; Microbial Colonization

Keywords

fermented whey; microbiota; gut health; butyrate

Outcome Measures

Primary Outcomes (3)

• Faecal butyrate concentration - comparing upper and lower tertile of volunteers

  Change in relative proportion of butyrate (percentage of total SCFA - sum of propionate, butyrate, acetate, valerate, iso-valerate, iso-butyrate, succinate, lactate mM (millimolar values from gas chromatography) and absolute concentration (mM millimolar) when comparing volunteers as stratified by faecal butyrate levels at start of study. A comparison will be made between the butyrate concentration-dependent groupings.

  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

• Faecal butyrate concentration - intervention group effect

  Change in relative proportion of butyrate (percentage of total SCFA) and absolute concentration (mM, millimolar) across the total study group

  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

• Microbiota composition change

  Changes in the composition of the microbiota will be based on next-generation sequence analysis of 16S rRNA (ribosomal ribonucleic acid) genes extracted from faecal samples provided by all volunteers

  Assessed as change between day 0 and day 56

Secondary Outcomes (6)

• Gastrointestinal wellness questionnaire

  Day 0, 7, 14, 21, 28, 35, 42, 49 and 56

• Glucose tolerance and insulin sensitivity

  Measured on Day 0 and Day 56

• Health related quality of life questionnaire

  scored on Day 0 and 56

• Small intestinal fermentation

  measured on Days 0, 14 and 56

• Faecal pH

  measured at day 0 and 56

Study Arms (1)

Fermented whey concentrate

EXPERIMENTAL

Volunteers will receive the premixed water and fermented whey in weekly deliveries in 1.5L bottles and a drinking glass with a clear indication of the required 200ml volume. Participants will be asked to drink 200 ml of the supplemented water twice daily for the active intervention period.

Dietary Supplement: Fermented whey concentrate

Interventions

Fermented whey concentrate DIETARY_SUPPLEMENT

The investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal.

Also known as: Molkosan

Fermented whey concentrate

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• A. Vogel: collaborator

Study Sites (1)

The Rowett Institute, Human Nutrition Unit

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra M Johnstone, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Karen P Scott, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The intervention will be provided in non-descript bottles. Fermented whey is mixed with sugar-free flavoured water to mask its taste from participants.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stratified single arm study

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 18, 2019
• Study Start: March 13, 2019
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)