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

Long-term Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Fasting & Postprandial Cardiometabolic Health; The LoPoCardio - Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04851041
Acronym
LoPoCardio
Enrollment
56
Registered
2021-04-20
Start date
2021-03-03
Completion date
2024-05-01
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism, Lipid Metabolism

Keywords

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

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.

Interventions

OTHERPotato

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

OTHERPasta/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.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

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

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic glucose metabolismpre- 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.

Secondary

MeasureTime frameDescription
Postprandial TAG metabolism12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)Following a high-fat, high-carb meal, measured by plasma TAG.
Fatigue12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)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
Cognitive performance12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)Assessed with a validated neuropsychological test battery (CANTAB)
Venular and arteriolar diameters12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)Assessed via fundus photography
Office blood pressure12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)Measured by office blood pressure monitor in all visits
36h blood pressure profiles12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)Assessed via wearables blood pressure monitor
Lipid metabolism12 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
Glucose metabolism12 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
Low grade inflammation12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)Measured by inflammation plasma markers (hsCPR, IL6, IL8, TNFa)
Postprandial glucose metabolism12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)Following a high-fat, high-carb meal, measured by plasma glucose, insulin.
24h urine samples micronutrient profiles12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)Measured by 24 urine collection.
Quality of life questionnaire12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)Assessed with a 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated quality of life)
Mood, degree of pleasantness and arousal12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)Assessed with the Affect grid

Other

MeasureTime frameDescription
Exploratory objective calculated insulin secretory function12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)Measured by HOMA%B index
Exploratory objective micro-albumineria and kidney function12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)Measured by estimated GFR
Exploratory objective plasma incretins / satiety hormones in fasting and postprandial conditions12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)Following a high-fat, high-carb meal, measured by PYY, GLP, ghrelin.
Exploratory objective endothelial (dys)function markers12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)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)
Exploratory objective liver enzymes12 weeks intervention: Pre-intervention (visit 1 and 2), during the intervention (visit 3, 4, 5) and post intervention (visit 6, and 7)Measured by liver enzymes (ALAT, ASAT, gGT, bilirubin)

Countries

Netherlands

Contacts

Primary ContactMarco Antonio MA Chávez Alfaro, Msc
m.chavezalfaro@maastrichtuniversity.nl0627437809
Backup ContactJogchum Plat, PhD
J.Plat@maastrichtuniversity.nl+31-43-3881309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026