Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health

Maastricht University Medical Center63 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Glucose Metabolism Lipid Metabolism

Interventions

10 g of collagen hydrolysateDIETARY_SUPPLEMENT

Before breakfast, participants consume 1 sachet every day for 4 weeks. The sachet contains 10-gram collagen protein hydrolysates + 5-gram erythritol and it has to be dissolved in 250 ml of water.

PlaceboDIETARY_SUPPLEMENT

Before breakfast, participants consume 1 sachet every day for 4 weeks. The sachet contains 5-gram erythritol (placebo) and has to be dissolved in 250 ml of water.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maastricht University Medical Center

Maastricht, Netherlands

Outcomes

Primary Outcomes

Chronic glucose metabolism

Measured by change in average daily glucose concentrations over a 15 hours period between waking up and going to bed 7:00-22:00 for three days, which is calculated based on the total area under the curve (tAUC) using a continuous glucose monitor.

Time frame: pre- intervention and during the fourth week of intervention.

Secondary Outcomes

Lipid metabolism

Measured by fasting serum, lipids and lipoproteins in all visits

Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5)

Glucose metabolism

Measured by fasting plasma glucose, and insulin in all visits

Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5)

Low-grade inflammation

Measured by inflammation plasma markers (Interleukin-6, Interleukin-8)

Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5)

Postprandial glucose metabolism

Following a high-fat, high-carb meal, measured by plasma glucose, insulin.

Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)

Postprandial triacylglyceride metabolism

Following a high-fat, high-carb meal, measured by plasma triacylglyceride.

Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)

Data from ClinicalTrials.gov

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