Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

The Use of Fermented Whey Concentrate in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Molkosan

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • The Rowett Institute, Human Nutrition Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Molkosan; Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiota activity	Faecal short-chain fatty acids, measured by gas chromatography	Baseline, day 21 and 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, day 21 and 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiota composition - 16s rRNA (ribosomal ribonucleic acid) sequencing	16S rRNA extracted from fresh stool samples (<16hrs)	Baseline, day 21 and 42
Subjective assessment of digestion and bowel movements	Volunteer self-reported symptoms measured by questionnaire	Baseline and day 14-18
Energy intake	4-day weighed food diary analysed for energy intake and macronutrient composition	Baseline and day 14-18
Blood pressure	Repeated in triplicate, measured in mmHg	Screening, baseline and day 42
Pulse	Triplicate measurement, expressed as beats per minute	Screening, baseline and day 42

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: A. Vogel
• Investigators: Principal Investigator: Alexandra M Johnstone, Ph.D, Rowett Institute, University of Aberdeen

Publications and helpful links

General Publications

• 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.

Helpful Links

• A. Vogel product website and description

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): July 7, 2015
• Study Completion (Actual): July 7, 2015

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Food supplement, Fermented food, Whey
• Other Study ID Numbers: 799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No