Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Cardiometabolic Health

NCT ID: NCT04851041

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2024-05-01

Brief Summary

The researchers investigate the effect of long-term (12-weeks) consumption of diets rich in boiled potatoes versus those rich in rice or pasta on established cardiovascular risk parameters. These carbohydrate sources will be part of a recommended healthy dietary pattern to mimic as closely as possible current dietary guidelines, facilitating the implementation of the outcomes.

Detailed Description

To breach the current controversies, there is an urgent need for well-designed controlled human intervention trials evaluating the true impact of boiled potato consumption as part of a healthy dietary pattern on cardiometabolic health. There are two important issues that need to be addressed when designing such an intervention study: First, the longer-term effects of boiled potato consumption on established fasting and postprandial cardiovascular risk markers should be addressed. Second, the effect of boiled potatoes should be studied using an iso-energetic exchange for other traditionally main carbohydrate sources. These carbohydrate-sources will be part of a recommended healthy dietary pattern to mimic as closely as possible current dietary guidelines, facilitating the implementation of the outcomes. Effects will be studied in both fasting and postprandial conditions. In fact, the evidence is accumulating that optimizing postprandial glucose and lipid responses are important targets for maintaining health. Since potatoes, white rice and white pasta are all products with a high glycemic index and concomitant relatively steep glucose excursions after intake, the question is how long-term intake of these products affects the metabolic capacity of our body to respond to postprandial challenges. Interestingly, potatoes are not only rich in complex carbohydrates but are also more nutrient-dense (a wide variety of minerals, vitamins, and micronutrients) as compared to white rice and white pasta. In addition, potatoes provide large amounts of fiber and are more satiating than other carbohydrate sources. This nutrient profile might beneficially impact the resilience of the metabolic machinery and as such improve postprandial cardiometabolic plasma profiles (glucose, insulin, and triacylglycerol). In other words, there might be a beneficial effect of longer-term potato consumption in comparison with longer-term white pasta and white rice consumption will not only be present in fasting conditions but particularly in the postprandial state when the cardiometabolic system is challenged.

Conditions

Glucose Metabolism; Lipid Metabolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Potato group

The participants in this group consume every day 150g of boiled potatoes for 12 weeks, preferably during dinner. The participants are allowed to eat this portion during lunch as well

Group Type: EXPERIMENTAL

Potato

Intervention Type: OTHER

Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health

Pasta/rice

The participants in this group consume every day either rice or pasta for 12 weeks, preferably during dinner. The participants are allowed to eat this portion during lunch as well.

The portion of rice and pasta must be as isocaloric as 150g of boiled potatoes.

Group Type: ACTIVE_COMPARATOR

Pasta/rice

Intervention Type: OTHER

Since potatoes, white rice and white pasta are all products with a high glycemic index and concomitant relatively steep glucose excursions after intake, this intervention group helps to compare the effect of potato vs another high glucemic index food.

Interventions

Potato

Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health

Intervention Type: OTHER

Pasta/rice

Since potatoes, white rice and white pasta are all products with a high glycemic index and concomitant relatively steep glucose excursions after intake, this intervention group helps to compare the effect of potato vs another high glucemic index food.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged between 40-70 years
• Men and women
• 18-70 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 < 4.5 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 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 ≥ 4.5 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 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jogchum J Plat, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair of Nutrition and Movement Science Department

Ronald P. Mensisnk, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair of Nutrition and Movement Science Department

Locations

Metabolic Research Unit Maastricht

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Marco Antonio MA Chávez Alfaro, Msc

Role: CONTACT

m.chavezalfaro@maastrichtuniversity.nl

0627437809

Jogchum Plat, PhD

Role: CONTACT

J.Plat@maastrichtuniversity.nl

+31-43-3881309

Facility Contacts

Marco Antonio C Alfaro, Masters

Role: primary

m.chavezalfaro@maastrichtuniversity.nl

0627437809

References

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Reference Type: BACKGROUND

PMID: 23674809 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19960391 (View on PubMed)

Other Identifiers

METC19-067

Identifier Type: -

Identifier Source: org_study_id