Clinical trial NCT04851041: Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Cardiometabolic Health
Official title: Long-term Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Fasting & Postprandial Cardiometabolic Health; The LoPoCardio - Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism
Lipid Metabolism
Keywords: Potato
pasta
rice
glucose metabolism
dietary patterns
Cardiometabolic health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longer-term (12-weeks) well-controlled intervention trial with a parallel design including 56 overweight and obese (BMI25-35 kg/m2) men and women
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are:
* 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:

* The exclusion criteria are:
* 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

Primary outcomes:
measure: Chronic glucose metabolism
timeFrame: pre- intervention and post- intervention (12 weeks)
Secondary outcomes:
measure: Lipid metabolism
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Glucose metabolism
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Low grade inflammation
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Postprandial glucose metabolism
timeFrame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
measure: Postprandial TAG metabolism
timeFrame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
measure: 24h urine samples micronutrient profiles
timeFrame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
measure: Quality of life questionnaire
timeFrame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
measure: Mood, degree of pleasantness and arousal
timeFrame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
measure: Fatigue
timeFrame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
measure: Cognitive performance
timeFrame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
measure: Venular and arteriolar diameters
timeFrame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
measure: Office blood pressure
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: 36h blood pressure profiles
timeFrame: 12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)
Other outcomes:
measure: Exploratory objective endothelial (dys)function markers
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Exploratory objective liver enzymes
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Exploratory objective calculated insulin secretory function
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Exploratory objective micro-albumineria and kidney function
timeFrame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
measure: Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions
timeFrame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
Locations:
city: Maastricht
country: Netherlands
facility: Metabolic Research Unit Maastricht
state: Limburg
Study officials:
affiliation: Chair of Nutrition and Movement Science Department
name: Jogchum J Plat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair of Nutrition and Movement Science Department
name: Ronald P. Mensisnk, PhD
role: PRINCIPAL_INVESTIGATOR
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