Glucose MetabolismNCT05282641
Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
A study testing 10 g of collagen hydrolysate in people with Glucose Metabolism and Lipid Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Lipid Metabolism
- What is being tested?
- 10 g of collagen hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 May 2021to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health in Obese (BMI 25-35 kg/m2) Men and Women With Elevated Risk to Develop Type-2 Diabetes and CVD
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.
Read the 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. 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
- Glucose Metabolism, Lipid Metabolism
- Being tested
- 10 g of collagen hydrolysate, Placebo
- Keywords
- Collagen hydrolysate, Glucose metabolism, Dietary patterns, Cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Collagen hydrolysate | Experimental | 30 subjects will consume the protein hydrolysate daily for 4 weeks Receives: Dietary Supplement: 10 g of collagen hydrolysate |
| Placebo | Placebo comparator | 30 subjects will consume the placebo daily for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre- intervention and during the fourth week of intervention.
Secondary outcomes (19)
Lipid metabolism
Measured by fasting serum, lipids and lipoproteins in all visits
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Quality of life questionnaire
Assessed with a 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life) Outcome Measures 1-5 (1= Bad, 2=Below Average, 3= Average, 4=Above Average, 5=Good .
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Mood, degree of pleasantness and arousal
Assessed with the Affect grid
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Perceived Stress Scale
Assessed using the Perceived Stress Scale Scale, a 10-item questionnaire that is used to determine individual stress levels experienced in the past weeks during daily activities. Scores ranging from 0-40 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Cognitive performance
Assessed with a validated neuropsychological test battery (Cambridge Neuropsychological Test Automated Battery) subjects will perform a neuropsychological test battery containing the anti-cue task (impulse control), the psychomotor vigilance test (sustained attention), the Attention Network Test, the N-Back task (working), the Rey Auditory Verbal Learning Task) (episodic memory), and the Trail Making Test (executive functioning).
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Venular and arteriolar diameters
Assessed via fundus photography
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Office blood pressure
Systolic and diastolic blood pressure measured by office blood pressure monitor in all visits
Measured: 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)
36-hours blood pressure profiles
Systolic and diastolic blood pressure assessed via wearable blood pressure monitor
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5)
Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI) Consisting of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by A total of seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Tumor necrosis factor alfa
Measured by inflammation plasma markers Tumor necrosis factor alfa
Measured: 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)
C-reactive Protein
Measured by inflammation plasma markers C-reactive Protein
Measured: 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)
Chronic glucose metabolism
Measured by fasting plasma glycated hemoglobin A1c
Measured: 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)
Insulin sensitivity
Measured by fasting calculated homeostasis model assessment of insulin resistance in all visits
Measured: 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)
C-peptide
Measured by fasting serum C-peptide
Measured: 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)
Cerebral blood flow (CBF)
Measured using a DWL Multi-Dop T digital device (Compumedics Germany GmbH, Singen, Germany)
Measured: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start26 May 2021
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 4-weeks randomized, controlled trial with a parallel design. Before the 4-weeks intervention, there is a 2-weeks run period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, PhD, Principal investigator, Chair of Nutrition and Movement Science Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282641
- Sponsor's protocol ID
- METC20-007
- Status last verified
- Oct 2023
- First submitted
- 17 Nov 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24482579Thomson 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.
PubMed 22098638Manninen AH. Protein hydrolysates in sports nutrition. Nutr Metab (Lond). 2009 Sep 28;6:38. doi: 10.1186/1743-7075-6-38.
PubMed 19785737de 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.
PubMed 29710777Saleh 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.
PubMed 28372849Power 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.
PubMed 24131508Benito-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.
PubMed 19212858Chavez-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.
PubMed 41288414Chavez-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.
PubMed 39889494
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health in Obese (BMI 25-35 kg/m2) Men and Women With Elevated Risk to Develop Type-2 Diabetes and CVD
- ClinicalTrials.gov ID
- NCT05282641
- Acronym / sponsor ID
- METC20-007
- Conditions
- Glucose Metabolism, Lipid Metabolism
- Keywords
- Collagen hydrolysate, Glucose metabolism, Dietary patterns, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A 4-weeks randomized, controlled trial with a parallel design. Before the 4-weeks intervention, there is a 2-weeks run period.
| Arm | Type | Receives |
|---|---|---|
| Collagen hydrolysate | Experimental | Dietary Supplement: 10 g of collagen hydrolysate30 subjects will consume the protein hydrolysate daily for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo30 subjects will consume the placebo daily for 4 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 g of collagen hydrolysateBefore 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. | Dietary supplement | Collagen hydrolysate |
| PlaceboBefore 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. | Dietary supplement | Placebo |
Primary outcome
Chronic glucose metabolism
Time frame: pre- intervention and during the fourth week of intervention.
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.
19 secondary outcomes
Lipid metabolism
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
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
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
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Postprandial triacylglyceride metabolism
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Quality of life questionnaire
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Mood, degree of pleasantness and arousal
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Perceived Stress Scale
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Cognitive performance
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Venular and arteriolar diameters
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Office blood pressure
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)
36-hours blood pressure profiles
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5)
Sleep Quality
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Tumor necrosis factor alfa
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)
C-reactive Protein
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)
Chronic glucose metabolism
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)
Insulin sensitivity
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)
C-peptide
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)
Cerebral blood flow (CBF)
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 24482579Manninen AH. Protein hydrolysates in sports and exercise: a brief review. J Sports Sci Med. 2004 Jun 1;3(2):60-3. eCollection 2004 Jun.
- Background: PubMed 22098638Thomson 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.
- Background: PubMed 19785737Manninen AH. Protein hydrolysates in sports nutrition. Nutr Metab (Lond). 2009 Sep 28;6:38. doi: 10.1186/1743-7075-6-38.
- Background: PubMed 29710777de 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.
- Background: PubMed 28372849Saleh 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.
- Background: PubMed 24131508Power 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.
- Background: PubMed 19212858Benito-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.
- Derived from this study: PubMed 41288414Chavez-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.
- Derived from this study: PubMed 39889494Chavez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogchum Plat, PhD principal investigator
Chair of Nutrition and Movement Science Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 g of collagen hydrolysate in people with Glucose Metabolism and Lipid Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic glucose metabolism (time frame: pre- intervention and during the fourth week of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282641, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.