Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

NCT ID: NCT03615339

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-16

Study Completion Date

2015-07-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Unlabelled bottles of treatment

Study Groups

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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.

Group Type EXPERIMENTAL

Molkosan

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Molkosan

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A. Vogel

UNKNOWN

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra M Johnstone, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute, University of Aberdeen

Locations

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The Rowett Institute, Human Nutrition Unit

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33102510 (View on PubMed)

Related Links

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https://www.avogel.co.uk/food/products/molkosan-digestion/

A. Vogel product website and description

Other Identifiers

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799

Identifier Type: -

Identifier Source: org_study_id

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