- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851041
Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Cardiometabolic Health (LoPoCardio)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jogchum Plat, PhD
- Phone Number: +31-43-3881309
- Email: J.Plat@maastrichtuniversity.nl
Study Contact Backup
- Name: Marco Antonio MA Chávez Alfaro, Msc
- Phone Number: 0627437809
- Email: m.chavezalfaro@maastrichtuniversity.nl
Study Locations
-
-
Limburg
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Maastricht, Limburg, Netherlands, NL-6200
- Recruiting
- Metabolic Research Unit Maastricht
-
Contact:
- Marco Antonio C Alfaro, Masters
- Phone Number: 0627437809
- Email: m.chavezalfaro@maastrichtuniversity.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health
|
Active Comparator: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic glucose metabolism
Time Frame: pre- intervention and post- intervention (12 weeks)
|
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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid metabolism
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
|
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)
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Glucose metabolism
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
|
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)
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Low grade inflammation
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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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)
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Postprandial glucose metabolism
Time Frame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
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Following a high-fat, high-carb meal, measured by plasma glucose, insulin.
|
12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
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Postprandial TAG metabolism
Time Frame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
|
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
Time Frame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
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Measured by 24 urine collection.
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12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
|
Quality of life questionnaire
Time Frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Assessed with a 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life)
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12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Mood, degree of pleasantness and arousal
Time Frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Assessed with the Affect grid
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12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Fatigue
Time Frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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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)
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Cognitive performance
Time Frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Assessed with a validated neuropsychological test battery (CANTAB)
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12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Venular and arteriolar diameters
Time Frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Assessed via fundus photography
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12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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Office blood pressure
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Measured by office blood pressure monitor in all visits
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12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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36h blood pressure profiles
Time Frame: 12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)
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Assessed via wearables blood pressure monitor
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12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory objective endothelial (dys)function markers
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Measured by sE-selectin, sICAM, sVCAM, and MCP-1 in al visits To investigate if potato consumption by overweight and obese (BMI25-35 kg/m2) men and women changes:
|
12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Exploratory objective liver enzymes
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Measured by liver enzymes (ALAT, ASAT, gGT, bilirubin)
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12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Exploratory objective calculated insulin secretory function
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Measured by HOMA%B index
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12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Exploratory objective micro-albumineria and kidney function
Time Frame: 12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Measured by estimated GFR
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12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
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Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions
Time Frame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
|
Following a high-fat, high-carb meal, measured by PYY, GLP, ghrelin.
|
12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
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Collaborators and Investigators
Investigators
- Principal Investigator: Jogchum J Plat, PhD, Chair of Nutrition and Movement Science Department
- Principal Investigator: Ronald P. Mensisnk, PhD, Chair of Nutrition and Movement Science Department
Publications and helpful links
General Publications
- Seidelmann SB, Claggett B, Cheng S, Henglin M, Shah A, Steffen LM, Folsom AR, Rimm EB, Willett WC, Solomon SD. Dietary carbohydrate intake and mortality: a prospective cohort study and meta-analysis. Lancet Public Health. 2018 Sep;3(9):e419-e428. doi: 10.1016/S2468-2667(18)30135-X. Epub 2018 Aug 17.
- Shan Z, Rehm CD, Rogers G, Ruan M, Wang DD, Hu FB, Mozaffarian D, Zhang FF, Bhupathiraju SN. Trends in Dietary Carbohydrate, Protein, and Fat Intake and Diet Quality Among US Adults, 1999-2016. JAMA. 2019 Sep 24;322(12):1178-1187. doi: 10.1001/jama.2019.13771.
- Simpson SJ, Le Couteur DG, James DE, George J, Gunton JE, Solon-Biet SM, Raubenheimer D. The Geometric Framework for Nutrition as a tool in precision medicine. Nutr Healthy Aging. 2017 Dec 7;4(3):217-226. doi: 10.3233/NHA-170027.
- Robertson TM, Alzaabi AZ, Robertson MD, Fielding BA. Starchy Carbohydrates in a Healthy Diet: The Role of the Humble Potato. Nutrients. 2018 Nov 14;10(11):1764. doi: 10.3390/nu10111764.
- Jacome-Sosa M, Parks EJ, Bruno RS, Tasali E, Lewis GF, Schneeman BO, Rains TM. Postprandial Metabolism of Macronutrients and Cardiometabolic Risk: Recent Developments, Emerging Concepts, and Future Directions. Adv Nutr. 2016 Mar 15;7(2):364-74. doi: 10.3945/an.115.010397. Print 2016 Mar.
- King JC, Slavin JL. White potatoes, human health, and dietary guidance. Adv Nutr. 2013 May 1;4(3):393S-401S. doi: 10.3945/an.112.003525.
- Camire ME, Kubow S, Donnelly DJ. Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- METC19-067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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