Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health

NCT05282641 | Completed

• 1 other identifier: METC20-007
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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 have a disturbed lipid and glucose metabolism and increased risk to develop cardiovascular disease and/or Type- 2 diabetes.

Conditions

Glucose Metabolism; Lipid Metabolism

Keywords

Collagen hydrolysate; Glucose metabolism; Dietary patterns; Cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• 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.

  pre- intervention and during the fourth week of intervention.

Secondary Outcomes (19)

• Lipid metabolism

  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

  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

  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

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

• Postprandial triacylglyceride metabolism

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

Other Outcomes (5)

• Exploratory objective endothelial (dys)function markers

  2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)

• Exploratory objective liver enzymes

  2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)

• Exploratory objective calculated insulin secretory function

  2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)

Study Arms (2)

Collagen hydrolysate

EXPERIMENTAL

30 subjects will consume the protein hydrolysate daily for 4 weeks

Dietary Supplement: 10 g of collagen hydrolysate

Placebo

PLACEBO COMPARATOR

30 subjects will consume the placebo daily for 4 weeks

Dietary Supplement: Placebo

Interventions

10 g of collagen hydrolysate 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.

Collagen hydrolysate

Placebo 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.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229ER, Netherlands

Location

Related Publications (9)

• Manninen AH. Protein hydrolysates in sports and exercise: a brief review. J Sports Sci Med. 2004 Jun 1;3(2):60-3. eCollection 2004 Jun.

  PMID: 24482579 BACKGROUND

• Thomson RL, Buckley JD. Protein hydrolysates and tissue repair. Nutr Res Rev. 2011 Dec;24(2):191-7. doi: 10.1017/S0954422411000084. Epub 2011 Nov 21.

  PMID: 22098638 BACKGROUND

• Manninen AH. Protein hydrolysates in sports nutrition. Nutr Metab (Lond). 2009 Sep 28;6:38. doi: 10.1186/1743-7075-6-38.

  PMID: 19785737 BACKGROUND

• de Campos Zani SC, Wu J, Chan CB. Egg and Soy-Derived Peptides and Hydrolysates: A Review of Their Physiological Actions against Diabetes and Obesity. Nutrients. 2018 Apr 28;10(5):549. doi: 10.3390/nu10050549.

  PMID: 29710777 BACKGROUND

• Saleh L, Schrier NL, Bruins MJ, Steegers EAP, van den Meiracker AH, Visser W. Effect of oral protein hydrolysate on glucose control in patients with gestational diabetes. Clin Nutr. 2018 Jun;37(3):878-883. doi: 10.1016/j.clnu.2017.03.009. Epub 2017 Mar 16.

  PMID: 28372849 BACKGROUND

• Power O, Nongonierma AB, Jakeman P, FitzGerald RJ. Food protein hydrolysates as a source of dipeptidyl peptidase IV inhibitory peptides for the management of type 2 diabetes. Proc Nutr Soc. 2014 Feb;73(1):34-46. doi: 10.1017/S0029665113003601. Epub 2013 Oct 17.

  PMID: 24131508 BACKGROUND

• Benito-Ruiz P, Camacho-Zambrano MM, Carrillo-Arcentales JN, Mestanza-Peralta MA, Vallejo-Flores CA, Vargas-Lopez SV, Villacis-Tamayo RA, Zurita-Gavilanes LA. A randomized controlled trial on the efficacy and safety of a food ingredient, collagen hydrolysate, for improving joint comfort. Int J Food Sci Nutr. 2009;60 Suppl 2:99-113. doi: 10.1080/09637480802498820. Epub 2009 Feb 11.

  PMID: 19212858 BACKGROUND

• Chavez-Alfaro MA, Mensink RP, Joris PJ, Plat J. Effects of porcine-derived collagen hydrolysates on 24 h blood pressure profiles, markers for endothelial dysfunction and low-grade inflammation and the retinal vasculature in adults with overweight/obesity: a randomized, controlled trial. Food Funct. 2025 Dec 8;16(24):9562-9571. doi: 10.1039/d5fo01261a.

  PMID: 41288414 DERIVED

• Chavez-Alfaro MA, Mensink RP, Plat J. Effects of four-weeks porcine-collagen hydrolysate consumption on glucose concentrations, glycemic variability, and fasting/postprandial cardiometabolic risk markers in men and women with overweight or obesity: A randomized, controlled trial. Clin Nutr. 2025 Mar;46:60-71. doi: 10.1016/j.clnu.2025.01.018. Epub 2025 Jan 22.

  PMID: 39889494 DERIVED

Study Officials

• Jogchum Plat, PhD

  Chair of Nutrition and Movement Science Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: March 16, 2022
• Study Start: May 26, 2021
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)