Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

University of Aberdeen22 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MolkosanDIETARY_SUPPLEMENT

Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Rowett Institute, Human Nutrition Unit

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

Change in microbiota activity

Faecal short-chain fatty acids, measured by gas chromatography

Time frame: Baseline, day 21 and 42

Secondary Outcomes

Change in glucose tolerance (Oral glucose tolerance test (OGTT)

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.

Time frame: Baseline, day 21 and 42

Data from ClinicalTrials.gov

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