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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03615339
Other study ID # 799
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2015
Est. completion date July 7, 2015

Study information

Verified date July 2018
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date July 7, 2015
Est. primary completion date July 7, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom The Rowett Institute, Human Nutrition Unit Aberdeen

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen A. Vogel

Country where clinical trial is conducted

United Kingdom, 

Outcome

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