Healthy Clinical Trial
Official title:
The Use of Fermented Whey Concentrate in Healthy Adults
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 |
Verified date | July 2018 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM & PM).
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Rowett Institute, Human Nutrition Unit | Aberdeen |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen | A. Vogel |
United Kingdom,
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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