Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-08-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects the Glycemic Index on Metabolic Risk Markers

NCT00695825

Metabolic Syndrome X

COMPLETED NA

Dietary Interventions in Prediabetes

NCT01729078

Impaired Fasting Glucose Pre Diabetes Liver Fat

COMPLETED NA

Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome

NCT01040663

Obesity

COMPLETED NA

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

NCT02119325

Impaired Fasting Glucose

COMPLETED NA

Effect of Daily Glucomannan in Overweight Patients

NCT01485718

Overweight Obesity

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glucose Metabolism Lipid Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 4-weeks randomized, controlled trial with a parallel design. Before the 4-weeks intervention, there is a 2-weeks run period.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

The subjects will follow one of the two experimental conditions. The decision in which condition they will be placed is based upon a computer-generated table with random numbers. For this, a categorical list in logical order will be created by an independent person before the start of the study. After being found eligible to start the study, the subject gets the following study number that is on the list. Basically, this entire randomization process is blinded and follows the concealed allocation procedures. During this process, it will safeguard that there are equal group sizes and an equal number of men and women in both groups (range 40/60% or 60/40% is accepted).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Collagen hydrolysate

30 subjects will consume the protein hydrolysate daily for 4 weeks

Group Type EXPERIMENTAL

10 g of collagen hydrolysate

Intervention Type DIETARY_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.

Placebo

30 subjects will consume the placebo daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10 g of collagen hydrolysate

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes