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

NCT04851041 | Unknown

• 1 other identifier: METC19-067
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism; Lipid Metabolism

Keywords

Potato; pasta; rice; glucose metabolism; dietary patterns; Cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Lipid metabolism

  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

  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

  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

  12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)

• Postprandial TAG metabolism

  12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)

Other Outcomes (5)

• Exploratory objective endothelial (dys)function markers

  12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)

• Exploratory objective liver enzymes

  12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)

• Exploratory objective calculated insulin secretory function

  12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)

Study Arms (2)

Potato group

EXPERIMENTAL

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

Pasta/rice

ACTIVE COMPARATOR

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

Interventions

Potato OTHER

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

Potato group

Pasta/rice 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.

Pasta/rice

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40-70 years
• Men and women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Metabolic Research Unit Maastricht

Maastricht, Limburg, NL-6200, Netherlands

RECRUITING

Related Publications (7)

• 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.

  PMID: 30122560 BACKGROUND

• 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.

  PMID: 31550032 BACKGROUND

• 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.

  PMID: 29276791 BACKGROUND

• 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.

  PMID: 30441846 BACKGROUND

• 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.

  PMID: 26980820 BACKGROUND

• 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.

  PMID: 23674809 BACKGROUND

• 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.

  PMID: 19960391 BACKGROUND

Study Officials

• Jogchum J Plat, PhD

  Chair of Nutrition and Movement Science Department

  PRINCIPAL INVESTIGATOR

• Ronald P. Mensisnk, PhD

  Chair of Nutrition and Movement Science Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Antonio MA Chávez Alfaro, Msc

CONTACT

0627437809; m.chavezalfaro@maastrichtuniversity.nl

Jogchum Plat, PhD

CONTACT

+31-43-3881309; J.Plat@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longer-term (12-weeks) well-controlled intervention trial with a parallel design including 56 overweight and obese (BMI25-35 kg/m2) men and women

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 20, 2021
• Study Start: March 3, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)