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Long-term effects of a potato-based food pattern vs a rice / pasta-based food pattern on fasting & postprandial cardiometabolic health; The LoPoCardio - trial

Long-term effects of a potato-based food pattern vs a rice / pasta-based food pattern on fasting & postprandial cardiometabolic health; The LoPoCardio - trial - Potatoes and cardiometabolic health

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56420
Enrollment
56
Registered
2019-12-24
Start date
2021-03-03
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes glucose metabolism

Interventions

During the intervention period, 28 subjects will consume a potato-based dietary pattern providing about 300 gr boiled potatoes daily. This will be compared with a group of 28 subjects consuming a wh

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Men and women - Aged between 40-70 years - BMI between 25-35 kg/m2 (overweight and obese) - Serum total cholesterol = 8.0 mmol/L] according to the Standard for cardiovascular risk management of the Dutch general practitioners community [NHG]) - Serum triacylglycerol

Exclusion criteria

Exclusion criteria: - 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 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

Design outcomes

Primary

MeasureTime frame
In order to examine the impact of potato versus pasta / rice consumption on chronic glucose metabolism the primary outcome parameter of this study is a change in average daily glucose concentration measured over a 15 hours period between waking up and going to bed 7:00AM - 22:00PM for three consecutive days.

Secondary

MeasureTime frame
To investigate if potato consumption changes glucose metabolism, lipid metabolism and low-grade inflammation, general wellbeing, and vascular function.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)