Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Molkosan

• Registration Number: NCT03615339
• Lead Sponsor: University of Aberdeen

Brief Summary

Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM \& PM).

Detailed Description

Molkosan® is made from fresh organic whey using a special fermentation process involving lactic acid producing bacteria (L+ lactic acid 70g/L). The company, A.Vogel (Roggwil, Switzerland) will provide the product and we will collect biological samples for analysis in a proof of concept study design that will provide preliminary data for future larger studies.

Study Timeline

• Study Start: 2015-03-16
• Primary Completion: 2015-07-07
• Study Completion: 2015-07-07
• Study First Submitted: 2018-06-25
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• age 18-65
• BMI 18-40 kg/m-2

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molkosan	Molkosan	Consumption of Molkosan (fermented whey) 20ml to be diluted in 200ml water prior to use twice a day (morning \& evening). Total duration was 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in microbiota activity	Baseline, day 21 and 42	Faecal short-chain fatty acids, measured by gas chromatography

Secondary Outcome Measures

Name	Time	Method
Change in glucose tolerance (Oral glucose tolerance test (OGTT)	Baseline, day 21 and 42	Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level and insulin are analysed as total area under the curve (AUC) and incremental AUC.

Trial Locations

Locations (1)

The Rowett Institute, Human Nutrition Unit; 🇬🇧 Aberdeen, United Kingdom