Healthy
Conditions
Keywords
Food supplement, Fermented food, Whey
Brief summary
Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM & PM).
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.
Interventions
DIETARY_SUPPLEMENTMolkosan
Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water
Sponsors
University of Aberdeen
A. Vogel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Unlabelled bottles of treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiota activity | Baseline, day 21 and 42 | Faecal short-chain fatty acids, measured by gas chromatography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose tolerance (Oral glucose tolerance test (OGTT) | 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
| Measure | Time frame | Description |
|---|---|---|
| Energy intake | Baseline and day 14-18 | 4-day weighed food diary analysed for energy intake and macronutrient composition |
| Change in microbiota composition - 16s rRNA (ribosomal ribonucleic acid) sequencing | Baseline, day 21 and 42 | 16S rRNA extracted from fresh stool samples (\<16hrs) |
| Pulse | Screening, baseline and day 42 | Triplicate measurement, expressed as beats per minute |
| Blood pressure | Screening, baseline and day 42 | Repeated in triplicate, measured in mmHg |
| Subjective assessment of digestion and bowel movements | Baseline and day 14-18 | Volunteer self-reported symptoms measured by questionnaire |
Countries
United Kingdom
Outcome results
None listed