Status:
COMPLETED
Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Glucose Metabolism
Lipid Metabolism
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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 h...
Detailed Description
Food-derived bioactive peptides represent a source of health-enhancing components that have been reported to have cardiovascular health benefits in humans and may be incorporated in functional foods. ...
Eligibility Criteria
Inclusion
- 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 during the screening visit
- Willing to comply to study protocol during the study
- Agree to take porcine / animal-derived supplements (i.e. collagen)
- Informed consent signed
Exclusion
- Allergy or intolerance to collagen or collagen hydrolysates
- Serum total cholesterol ≥ 8.0 mmol/L
- Serum triacylglycerol ≥ 4.5 mmol/L
- Current smoker, or smoking cessation \<12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 4 alcoholic consumptions per day or 21 per week
- Unstable body weight (weight gain or loss \> 3 kg in the past three months)
- Use medication known to treat blood pressure, lipid, or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- 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
- Active cardiovascular diseases like congestive heart failure or cardiovascular events, such as an acute myocardial infarction or cerebrovascular accident
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study, or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
- Use of over-the-counter and prescribed medication or supplements, which may interfere with study measurements to be judged by the principal investigator;
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Blood donation in the past 3 months before the start of the study
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05282641
Start Date
May 26 2021
End Date
August 24 2023
Last Update
November 18 2023
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Netherlands, 6229ER