Glucose MetabolismLoPoCardioNCT04851041
Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Cardiometabolic Health
A study testing Potato and Pasta/rice in people with Glucose Metabolism and Lipid Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Lipid Metabolism
- What is being tested?
- Potato and Pasta/rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Mar 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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])
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Metabolic Research Unit Maastricht
Maastricht, Limburg, NL-6200
Marco Antonio C Alfaro, Masters, 0627437809, m.chavezalfaro@maastrichtuniversity.nl
About this study
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
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.
Read the 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.
- Conditions
- Glucose Metabolism, Lipid Metabolism
- Being tested
- Potato, Pasta/rice
- Keywords
- Potato, pasta, rice, glucose metabolism, dietary patterns, Cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PotatoOther
Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health
Pasta/riceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Pasta/rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre- intervention and post- intervention (12 weeks)
Secondary outcomes (13)
Lipid metabolism
Measured by fasting serum C-peptide, lipids and lipoproteins in all visits
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
24h urine samples micronutrient profiles
Measured by 24 urine collection.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start3 Mar 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogchum J Plat, PhD, Principal investigator, Chair of Nutrition and Movement Science DepartmentRonald P. Mensisnk, PhD, Principal investigator, Chair of Nutrition and Movement Science Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851041
- Sponsor's protocol ID
- METC19-067
- Acronym
- LoPoCardio
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30122560Shan 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.
PubMed 31550032Simpson 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.
PubMed 29276791Robertson 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.
PubMed 30441846Jacome-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.
PubMed 26980820King 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.
PubMed 23674809Camire ME, Kubow S, Donnelly DJ. Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996.
PubMed 19960391
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04851041
- Acronym / sponsor ID
- LoPoCardio / METC19-067
- Conditions
- Glucose Metabolism, Lipid Metabolism
- Keywords
- Potato, pasta, rice, glucose metabolism, dietary patterns, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Potato group | Experimental | Other: PotatoThe 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 |
| Pasta/rice | Active comparator | Other: Pasta/riceThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The inclusion criteria are:
- Aged between 40-70 years
- Men and women
- 18-70 years
- BMI between 25-35 kg/m2 (overweight and obese)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PotatoControlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health | Other | Potato group |
| Pasta/riceSince 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. | Other | Pasta/rice |
Primary outcome
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.
13 secondary outcomes
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)
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)
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)
Postprandial glucose metabolism
Time frame: 12 weeks intervention: Pre-intervention (visit 2) and post intervention (visit 7)
Postprandial TAG metabolism
Time frame: 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)
Quality of life questionnaire
Time frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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)
Fatigue
Time frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
Cognitive performance
Time frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
Venular and arteriolar diameters
Time frame: 12 weeks intervention: Pre-intervention (visit 2), during the intervention (visit 4) and post intervention (visit 7)
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)
36h blood pressure profiles
Time frame: 12 weeks intervention: Pre- intervention (visit-1) and post- intervention (visit 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Background: PubMed 30122560Seidelmann 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.
- Background: PubMed 31550032Shan 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.
- Background: PubMed 29276791Simpson 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.
- Background: PubMed 30441846Robertson 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.
- Background: PubMed 26980820Jacome-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.
- Background: PubMed 23674809King 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.
- Background: PubMed 19960391Camire ME, Kubow S, Donnelly DJ. Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogchum J Plat, PhD principal investigator
Chair of Nutrition and Movement Science Department
Ronald P. Mensisnk, PhD principal investigator
Chair of Nutrition and Movement Science Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potato and Pasta/rice in people with Glucose Metabolism and Lipid Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Antonio MA Chávez Alfaro, Msc (0627437809, m.chavezalfaro@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic glucose metabolism (time frame: pre- intervention and post- intervention (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851041, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.