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

Study Overview
=================
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.

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

Conditions
-----------------
Glucose Metabolism, Lipid Metabolism

Intervention / Treatment
-----------------
* Other: Potato
* Other: Pasta/rice


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potato group<br>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 | Other: Potato<br>* Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health<br>|
| Active Comparator: Pasta/rice<br>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. | Other: Pasta/rice<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic glucose metabolism | Measured by change in average daily glucose concentrations over a 15 hours period between waking up and going to bed 7:00AM - 22:00PM for three days, which is calculated based on the total area under the curve (tAUC) using a continuos glucose monitor. | pre- intervention and post- intervention (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid metabolism | Measured by fasting serum C-peptide, lipids and lipoproteins in all visits | 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7) | 
| Glucose metabolism | Measured by fasting plasma glucose, insulin, and calculated HOMA- IR in all visits | 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7) | 
| Low grade inflammation | Measured by inflammation plasma markers (hsCPR, IL6, IL8, TNFa) | 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7) | 
| Postprandial glucose metabolism | Following a high-fat, high-carb meal, measured by plasma glucose, insulin. | 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7) | 
| Postprandial TAG metabolism | Following a high-fat, high-carb meal, measured by plasma TAG. | 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7) | 
| 24h urine samples micronutrient profiles | Measured by 24 urine collection. | 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7) | 
| Quality of life questionnaire | Assessed with a 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life) | 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7) | 
| Mood, degree of pleasantness and arousal | Assessed with the Affect grid | 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7) | 
| Fatigue | Assessed using the FSS, a 9-item questionnaire that is used to determine the severity of fatigue a subject experienced in the past week during daily activities | 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7) | 
| Cognitive performance | Assessed with a validated neuropsychological test battery (CANTAB) | 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7) | 
| Venular and arteriolar diameters | Assessed via fundus photography | 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7) | 
| Office blood pressure | Measured by office blood pressure monitor in all visits | 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7) | 
| 36h blood pressure profiles | Assessed via wearables blood pressure monitor | 12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose metabolism, dietary patterns, Cardiometabolic health, Potato, pasta, rice