Maastricht University Medical Center
Maastricht, 6229ER, Netherlands
NCT Number: NCT05282641
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.
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Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Maastricht, 6229ER, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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)
Measured by fasting serum, lipids and lipoproteins in all visits
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)
Measured by fasting plasma glucose, and insulin in all visits
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)
Measured by inflammation plasma markers (Interleukin-6, Interleukin-8)
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Following a high-fat, high-carb meal, measured by plasma glucose, insulin.
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Following a high-fat, high-carb meal, measured by plasma triacylglyceride.
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
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 .
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
Assessed with the Affect grid
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
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.
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
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).
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Assessed via fundus photography
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)
Systolic and diastolic blood pressure measured by office blood pressure monitor in all visits
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5)
Systolic and diastolic blood pressure assessed via wearable blood pressure monitor
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5)
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.
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)
Measured by inflammation plasma markers 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)
Measured by inflammation plasma markers 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)
Measured by fasting plasma glycated hemoglobin A1c
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)
Measured by fasting calculated homeostasis model assessment of insulin resistance in all visits
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)
Measured by fasting serum C-peptide
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5)
Measured using a DWL Multi-Dop T digital device (Compumedics Germany GmbH, Singen, Germany)
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
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
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Measured by liver enzymes (alanine aminotransferase, aspartate transaminase , gamma-glutamyltransferase , bilirubin)
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Measured by The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B)
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and post intervention (visit 5)
Following a high-fat, high-carb meal, measured by peptide YY , glucagon-like peptide-1, ghrelin.
Time frame: 2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and post intervention (visit 4, and 5)
Measured by estimated glomerular filtration rate
Maastricht University Medical Center
Other
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
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