Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults
The Use of Fermented Whey Concentrate in Healthy Adults
1 other identifier
interventional
22
1 country
1
Brief Summary
Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM \& PM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Mar 2015
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2015
CompletedFirst Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedAugust 3, 2018
July 1, 2018
4 months
June 25, 2018
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in microbiota activity
Faecal short-chain fatty acids, measured by gas chromatography
Baseline, day 21 and 42
Secondary Outcomes (1)
Change in glucose tolerance (Oral glucose tolerance test (OGTT)
Baseline, day 21 and 42
Other Outcomes (5)
Change in microbiota composition - 16s rRNA (ribosomal ribonucleic acid) sequencing
Baseline, day 21 and 42
Subjective assessment of digestion and bowel movements
Baseline and day 14-18
Energy intake
Baseline and day 14-18
- +2 more other outcomes
Study Arms (1)
Molkosan
EXPERIMENTALConsumption of Molkosan (fermented whey) 20ml to be diluted in 200ml water prior to use twice a day (morning \& evening). Total duration was 6 weeks.
Interventions
Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water
Eligibility Criteria
You may qualify if:
- age 18-65
- BMI 18-40 kg/m-2
You may not qualify if:
- Diabetes
- Severe gastrointestinal disorders,
- Kidney disease,
- Thromboembolic or coagulation disease,
- Hepatic disease,
- Alcohol or any other substance abuse
- Gout
- Eating disorders
- Unregulated thyroid disease
- Dairy intolerance
- Antibiotic use within the last 3 months, including prescribed use
- Current prebiotic or prebiotic use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- A. Vogelcollaborator
Study Sites (1)
The Rowett Institute, Human Nutrition Unit
Aberdeen, AB25 2ZD, United Kingdom
Related Publications (1)
Smith NM, Maloney NG, Shaw S, Horgan GW, Fyfe C, Martin JC, Suter A, Scott KP, Johnstone AM. Daily Fermented Whey Consumption Alters the Fecal Short-Chain Fatty Acid Profile in Healthy Adults. Front Nutr. 2020 Sep 30;7:165. doi: 10.3389/fnut.2020.00165. eCollection 2020.
PMID: 33102510DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra M Johnstone, Ph.D
Rowett Institute, University of Aberdeen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Unlabelled bottles of treatment
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2018
First Posted
August 3, 2018
Study Start
March 16, 2015
Primary Completion
July 7, 2015
Study Completion
July 7, 2015
Last Updated
August 3, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share