The objective is to evaluate the effects of longer-term consumption of diets rich in boiled potatoes versus those rich in rice or pasta on established cardiovascular risk parameters.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
To investigate if potato consumption changes glucose metabolism, lipid
metabolism and low-grade inflammation, general wellbeing, and vascular
function.
Background summary
Current international dietary guidelines emphasize that the majority of our
energy intake should be carbohydrate-derived. These carbohydrates should have a
low glycemic index (low-GI). In addition, *low-carb* diets have received a lot
of attention lately, assuming that high intakes of carbohydrates result in
unhealthy metabolic profiles and concomitant disease developments. Given the
observations in the so-called blue zones, - areas of exceptional longevity
around the world -, it is questionable whether high intakes of
carbohydrate-rich staple foods (often with a high-GI) are indeed unhealthy. To
breach the current controversies and answer the question whether potatoes do
align with the current dietary guidelines, there is an urgent need for
well-designed controlled human intervention trials evaluating the true impact
of potato consumption as part of a healthy dietary pattern on cardiometabolic
health.
Study objective
The objective is to evaluate the effects of longer-term consumption of diets
rich in boiled potatoes versus those rich in rice or pasta on established
cardiovascular risk parameters.
Study design
A longer-term randomized well-controlled intervention trial with a parallel
design.
Intervention
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 white rice / white pasta-based dietary
pattern containing an iso-energetic amount of white rice / white pasta.
Study burden and risks
Venipuncture can occasionally cause a local hematoma or bruise to occur. Some
study subjects may report pain during venipuncture. Insertion of the cannula
can cause some discomfort and possible a hematoma or bruise. Some study
subjects may also report pain during the insertion of the cannula. In total
308.5 mL blood will be sampled spread over a timeframe of 12 weeks and 7 blood
sampling moments with at least three weeks between subsequent blood sampling
moments. All measurements are routine and are not expected to lead to physical
side effects.
During the postprandial tests, subjects have to stay at the university and may
not eat. The investigational products, i.e. the potatoes, pasta and rice
provided, are safe and also commercially available. In addition, all
ingredients to prepare the mixed meals for the postprandial test day are
commercially available in the supermarket and approved for human consumption.
There are no side effects for the milkshakes when used in our earlier
experiments.
Time investment for the participants is approximately 16.2 hours, excluding
travel time.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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 (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
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 <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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04851041 |
| CCMO | NL71526.068.19 |