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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Daily intake of 10 gram collagen protein hydrolysate by (BMI 25-35 kg/m2) men<br /><br>and women does not change glucose metabolism, as measured by change in average<br /><br>daily glucose concentrations measured over a 15 hours period between waking up<br /><br>and going to bed 7:00AM - 22:00PM for three days, which is calculated based on<br /><br>the total area under the curve (tAUC) over the entire 15 hours follow-up during<br /><br>these three days</p><br>

Secondary Outcome Measures