ong-term effects of a potato-based food pattern vs a rice / pasta-based food pattern on fasting & postprandial cardiometabolic health; The LoPoCardio - trial
- Conditions
- diabetesglucose metabolism10000546
- Registration Number
- NL-OMON56420
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
- Men and women
- Aged between 40-70 years
- BMI between 25-35 kg/m2 (overweight and obese)
- 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 < 4.52 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, 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
- Informed consent signed
- Allergy or intolerance to potatoes, pasta or rice
- Serum total cholesterol >= 8.0 mmol/L
- Serum triacylglycerol >= 4.52 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, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In order to examine the impact of potato versus pasta / rice consumption on<br /><br>chronic glucose metabolism the primary outcome parameter of this study is a<br /><br>change in average daily glucose concentration measured over a 15 hours period<br /><br>between waking up and going to bed 7:00AM - 22:00PM for three consecutive days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate if potato consumption changes glucose metabolism, lipid<br /><br>metabolism and low-grade inflammation, general wellbeing, and vascular<br /><br>function.</p><br>