Clinical trial NCT05282641: Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism
Lipid Metabolism
Keywords: Collagen hydrolysate
Glucose metabolism
Dietary patterns
Cardiometabolic health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 4-weeks randomized, controlled trial with a parallel design. Before the 4-weeks intervention, there is a 2-weeks run period.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic glucose metabolism
timeFrame: pre- intervention and during the fourth week of intervention.
Secondary outcomes:
measure: Lipid metabolism
timeFrame: 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)
measure: Glucose metabolism
timeFrame: 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)
measure: Low-grade inflammation
timeFrame: 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)
measure: Postprandial glucose metabolism
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
measure: Postprandial triacylglyceride metabolism
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
measure: Quality of life questionnaire
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
measure: Mood, degree of pleasantness and arousal
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
measure: Perceived Stress Scale
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
measure: Cognitive performance
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
measure: Venular and arteriolar diameters
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
measure: Office blood pressure
timeFrame: 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)
measure: 36-hours blood pressure profiles
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5)
measure: Sleep Quality
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
measure: Tumor necrosis factor alfa
timeFrame: 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)
measure: C-reactive Protein
timeFrame: 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)
measure: Chronic glucose metabolism
timeFrame: 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)
measure: Insulin sensitivity
timeFrame: 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)
measure: C-peptide
timeFrame: 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)
measure: Cerebral blood flow (CBF)
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Other outcomes:
measure: Exploratory objective endothelial (dys)function markers
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
measure: Exploratory objective liver enzymes
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
measure: Exploratory objective calculated insulin secretory function
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
measure: Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and post intervention (visit 5)
measure: Exploratory objective micro-albuminuria and kidney function
timeFrame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Chair of Nutrition and Movement Science Department
name: Jogchum Plat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Manninen AH. Protein hydrolysates in sports nutrition. Nutr Metab (Lond). 2009 Sep 28;6:38. doi: 10.1186/1743-7075-6-38.
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.
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.
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.
citation: 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.