Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health (NCT05282641) | Clinical Trial Compass
CompletedNot Applicable
Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
Netherlands63 participantsStarted 2021-05-26
Plain-language summary
The effects of a 10g/day collagen hydrolysate for a period of 4 weeks on glycemic control and cardiovascular health in a parallel design study using overweight/ obese men and women who are likely to have a disturbed lipid and glucose metabolism and increased risk to develop cardiovascular disease and/or Type- 2 diabetes.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* Aged between 40-75 years
* Men and women (in a ratio of 40/60 to 60/40)
* BMI between 25-35 kg/m2
* Serum total cholesterol \< 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia \[serum total cholesterol ≥ 8.0 mmol/L\] according to the Standard for cardiovascular risk management of the Dutch general practitioner's community \[Nederlands Huisartsen Genootschap\])
* Serum triacylglycerol \< 4.5 mmol/L
* No current smoker
* No diabetic patients
* No familial hypercholesterolemia
* No abuse of drugs
* Not more than 4 alcoholic consumption per day with a maximum of 21 per week??
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* No use of medication known to treat blood pressure, lipid or glucose metabolism
* No use of an investigational product within another biomedical intervention trial within the previous 1-month
* No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, autoinflammatory diseases, and rheumatoid arthritis
* No active cardiovascular disease like congestive heart failure or cardiovascular events, such as an acute myocardial infarction or cerebrovascular accident
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study, and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced …
What they're measuring
1
Chronic glucose metabolism
Timeframe: pre- intervention and during the fourth week of intervention.