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Completed

NCT Number: NCT03615339

Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rowett Institute, Human Nutrition Unit

Aberdeen, AB25 2ZD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molkosan

Dietary Supplement

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

Primary outcomes

  1. Change in microbiota activity

    Time frame: Baseline, day 21 and 42

    Faecal short-chain fatty acids, measured by gas chromatography

Secondary outcomes

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

    Time frame: 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.

Other outcomes

  1. Change in microbiota composition - 16s rRNA (ribosomal ribonucleic acid) sequencing

    Time frame: Baseline, day 21 and 42

    16S rRNA extracted from fresh stool samples (<16hrs)

  2. Subjective assessment of digestion and bowel movements

    Time frame: Baseline and day 14-18

    Volunteer self-reported symptoms measured by questionnaire

  3. Energy intake

    Time frame: Baseline and day 14-18

    4-day weighed food diary analysed for energy intake and macronutrient composition

  4. Blood pressure

    Time frame: Screening, baseline and day 42

    Repeated in triplicate, measured in mmHg

  5. Pulse

    Time frame: Screening, baseline and day 42

    Triplicate measurement, expressed as beats per minute

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • A. Vogel

Registry information

Official study title

The Use of Fermented Whey Concentrate in Healthy Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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