Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Lipid Metabolism; Glucose Metabolism

Treatments: Dietary Supplement: 10 g of collagen hydrolysate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05282641

METC20-007

Details and patient eligibility

About

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.

Full 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. Up till now studies using collagen hydrolysates particularly addressed issues around joint health, however, there are some preliminary indications that other health-related targets might be affected as well. We here propose to focus on the potential effects of collagen hydrolysates on glycemic control, and characteristics of the microcirculation, both important parameters for the assessment of future cardiovascular disease (CVD) risk.

Enrollment: 63 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Collagen hydrolysate

Experimental group

Description:

30 subjects will consume the protein hydrolysate daily for 4 weeks

Treatment:

Dietary Supplement: 10 g of collagen hydrolysate

Placebo

Placebo Comparator group

Description:

30 subjects will consume the placebo daily for 4 weeks

Treatment:

Dietary Supplement: Placebo