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

Glucose Metabolism Clinical Trial

— LoPoCardio  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851041
• Other study ID #: METC19-067
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2021
• Source: Maastricht University Medical Center
• Contact: Marco Antonio MA Chávez Alfaro, Msc
• Phone: 0627437809
• Email: m.chavezalfaro[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism
• Lipid Metabolism

Intervention

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

Locations

Country	Name	City	State
Netherlands	Metabolic Research Unit Maastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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). pii: E1764. doi: 10.3390/nu10111764. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory objective endothelial (dys)function markers	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: Endothelial (dys)function markers (sE-selectin, sICAM, sVCAM, and MCP-1) - Liver enzymes (e.g. ALAT, ASAT, gGT, bilirubin); Calculated insulin secretory function (HOMA%B index); Micro-albumineria and kidney function (estimated GFR); Plasma incretins / satiety hormones (PYY, GLP, Ghrelin)	12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
Other	Exploratory objective liver enzymes	Measured by liver enzymes (ALAT, ASAT, gGT, bilirubin)	12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
Other	Exploratory objective calculated insulin secretory function	Measured by HOMA%B index	12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
Other	Exploratory objective micro-albumineria and kidney function	Measured by estimated GFR	12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)
Other	Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions	Following a high-fat, high-carb meal, measured by PYY, GLP, ghrelin.	12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	24h urine samples micronutrient profiles	Measured by 24 urine collection.	12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	36h blood pressure profiles	Assessed via wearables blood pressure monitor	12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)