Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health

Glucose Metabolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282641
• Other study ID #: METC20-007
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: August 24, 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 diabetes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism
• Lipid Metabolism

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory objective endothelial (dys)function markers	Measured by soluble endothelial molecule E-selectin, intercellular adhesion molecule-1, Circulating Vascular Cell Adhesion Molecule-1, and Monocyte Chemoattractant Protein-1 in al visits	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Other	Exploratory objective liver enzymes	Measured by liver enzymes (alanine aminotransferase, aspartate transaminase , gamma-glutamyltransferase , bilirubin)	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Other	Exploratory objective calculated insulin secretory function	Measured by The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B)	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Other	Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions	Following a high-fat, high-carb meal, measured by peptide YY , glucagon-like peptide-1, ghrelin.	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and post intervention (visit 5)
Other	Exploratory objective micro-albuminuria and kidney function	Measured by estimated glomerular filtration rate	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Primary	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	Lipid metabolism	Measured by fasting serum, lipids and lipoproteins in all visits	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)
Secondary	Glucose metabolism	Measured by fasting plasma glucose, and insulin in all visits	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)
Secondary	Low-grade inflammation	Measured by inflammation plasma markers (Interleukin-6, Interleukin-8)	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)
Secondary	Postprandial glucose metabolism	Following a high-fat, high-carb meal, measured by plasma glucose, insulin.	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Secondary	Postprandial triacylglyceride metabolism	Following a high-fat, high-carb meal, measured by plasma triacylglyceride.	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Secondary	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 .	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Secondary	Mood, degree of pleasantness and arousal	Assessed with the Affect grid	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Secondary	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.	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Secondary	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).	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Secondary	Venular and arteriolar diameters	Assessed via fundus photography	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Secondary	Office blood pressure	Systolic and diastolic blood pressure measured by office blood pressure monitor in all visits	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)
Secondary	36-hours blood pressure profiles	Systolic and diastolic blood pressure assessed via wearable blood pressure monitor	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5)
Secondary	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.	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Secondary	Tumor necrosis factor alfa	Measured by inflammation plasma markers Tumor necrosis factor alfa	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)
Secondary	C-reactive Protein	Measured by inflammation plasma markers C-reactive Protein	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)
Secondary	Chronic glucose metabolism	Measured by fasting plasma glycated hemoglobin A1c	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)
Secondary	Insulin sensitivity	Measured by fasting calculated homeostasis model assessment of insulin resistance in all visits	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)
Secondary	C-peptide	Measured by fasting serum C-peptide	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)
Secondary	Cerebral blood flow (CBF)	Measured using a DWL Multi-Dop T digital device (Compumedics Germany GmbH, Singen, Germany)	2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)