diabetes glucose metabolism
Conditions
Interventions
During the intervention period, 30 subjects will consume 10 gram collagen
protein hydrolysate daily, while another group consumes a placebo (N=30).
Sponsors
Voeding en Bewegingswetenschappen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged between 40-75 years - Men and women - 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 practitioners community [NHG]) - 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 in the previous 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, auto inflammatory diseases and rheumatoid arthritis - No active cardiovascular disease like congestive heart failure or cardiovascular event, 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 study - Agree to take porcine / animal derived supplements (i.e. collagen) - Informed consent signed
Exclusion criteria
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 in another biomedical intervention within the previous 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, auto inflammatory diseases and rheumatoid arthritis - Active cardiovascular disease like congestive heart failure or cardiovascular event, 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 - Not willing to comply to study protocol during study or sign informed consent - Not willing to consume the collagen hydrolysate because this is from animal origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men and women does not change glucose metabolism, as measured by change in average daily glucose concentrations measured over a 15 hours period between waking up and going to bed 7:00AM - 22:00PM for three days, which is calculated based on the total area under the curve (tAUC) over the entire 15 hours follow-up during these three days | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men and women changes glucose metabolism, lipid metabolism and low-grade inflammation as measured by: - Fasting serum lipids and lipoproteins (all blood samples); - Fasting plasma glucose, insulin, and C-peptide concentrations and calculated HOMA-IR (all blood samples); - Fasting low-grade inflammation plasma markers (hsCRP, IL6, IL8, TNFa) - Postprandial glucose metabolism following a high-fat, high-carb meal; - Postprandial TAG metabolism following a high-fat, high-carb meal; To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men and women changes general well being as measured by: - Quality of life, assessed with a 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life), - Mood, degree of pleasantness and arousal, as assessed with the Affect grid. - Fatigue as assessed using the FSS, a 9-item questionnaire that is used to determine the severity of fatigue a subject experienced in the past week during daily activities - Cognitive performance, assessed with a validated neuropsychological test battery (CANTAB) To investigate if daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men and women changes vascular function as measured by: - Venular and arteriolar diameters, assessed via fundus photography; - Office blood pressure (each visit); - 36-hour blood pressure profiles using wearables. -- Cerebral blood flow, assessed using transcranial doppler ultrasound | — |
Countries
Netherlands
Outcome results
None listed