Type 2 Diabetes MellitusNCT03495284
The Effect of Potatoes on Markers of Cardiometabolic Health
A study testing Potato-based side dish and Refined grain-based in people with Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Penn State University at 1 site in United States.
Trial summary
A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Potato-based side dish and Refined grain-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 19 Jan 2020
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking
- BMI > 20 and <40 kg/m2
- Male or female
Who cannot join
- Diagnosed diabetes or fasting glucose >126 mg/dl
- Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
- Pregnancy or lactation
- Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
- Smoking or use of any tobacco products
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.
Read the detailed description
A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Potato-based side dish, Refined grain-based
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato-based side dishDietary supplement
Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
Refined grain-basedDietary supplement
Daily consumption of an isocaloric refined grain-based side dish for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Potato treatment | Experimental | Participants will be provided with one potato-based side dish, equivalent to one medium sized potato, every day for 4 weeks for incorporation into their self-selected diet. The potato-based side dish will be prepared at the Penn State Metabolic Kitchen. The potato side dish will consist of commonly consumed potato-based sides in the U.S. and there will be limited inclusion of ingredients high in saturated fat, refined sugars or sodium. French fries will not be provided. The variety of potatoes will represent consumption patterns in the U.S. including white, russet, yellow and red potatoes. Receives: Dietary Supplement: Potato-based side dish |
| Refined grain treatment | Active comparator | Participants will be provided with a calorie-matched refined grain-based side dish every day for 4 weeks for incorporation into their self-selected diet. The refined grain-based side dishes will be prepared at the Penn State Metabolic Kitchen and ingredients high in saturated fat, refined sugar or sodium will not be used. These will be sides commonly eaten in the U.S. (e.g. pasta made with white flour and white rice, white bread rolls). During this treatment, participants will be told not to consume potatoes. Receives: Dietary Supplement: Refined grain-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Measured: 4 weeks
Secondary outcomes (12)
Homeostasis Model of Assessment of Insulin Resistance
Measured: 4 weeks
Peripheral blood pressure
Measured: 4 weeks
Central blood pressure
Measured: 4 weeks
Total cholesterol
Measured: 4 weeks
Pulse Wave Velocity
Measured: 4 weeks
Augmentation index
Measured: 4 weeks
Diet quality measured by the Healthy Eating Index 2010
Measured: 4 weeks
Change in fecal short chain fatty acid levels
Measured: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Change in microbiome composition
Measured: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
LDL cholesterol
Measured: 4 weeks
HDL cholesterol
Measured: 4 weeks
Triglycerides
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start19 Feb 2018
- Primary completion19 May 2019
- Study completion19 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495284
- Sponsor's protocol ID
- PKE POTATO
- Status last verified
- Aug 2023
- First submitted
- 15 Jan 2018
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Potatoes on Markers of Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03495284
- Acronym / sponsor ID
- PKE POTATO
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 Jan 2020 (actual)
- First posted
- 11 Apr 2018 (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.
A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.
Detailed description
A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potato treatment | Experimental | Dietary Supplement: Potato-based side dishParticipants will be provided with one potato-based side dish, equivalent to one medium sized potato, every day for 4 weeks for incorporation into their self-selected diet. The potato-based side dish will be prepared at the Penn State Metabolic Kitchen. The potato side dish will consist of commonly consumed potato-based sides in the U.S. and there will be limited inclusion of ingredients high in saturated fat, refined sugars or sodium. French fries will not be provided. The variety of potatoes will represent consumption patterns in the U.S. including white, russet, yellow and red potatoes. |
| Refined grain treatment | Active comparator | Dietary Supplement: Refined grain-basedParticipants will be provided with a calorie-matched refined grain-based side dish every day for 4 weeks for incorporation into their self-selected diet. The refined grain-based side dishes will be prepared at the Penn State Metabolic Kitchen and ingredients high in saturated fat, refined sugar or sodium will not be used. These will be sides commonly eaten in the U.S. (e.g. pasta made with white flour and white rice, white bread rolls). During this treatment, participants will be told not to consume potatoes. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-smoking
- BMI > 20 and <40 kg/m2
- Male or female
Key exclusion criteria (8 listed)
- Diagnosed diabetes or fasting glucose >126 mg/dl
- Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
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 |
|---|---|---|
| Potato-based side dishDaily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks | Dietary supplement | Potato treatment |
| Refined grain-basedDaily consumption of an isocaloric refined grain-based side dish for 4 weeks | Dietary supplement | Refined grain treatment |
Primary outcome
Fasting blood glucose
Time frame: 4 weeks
12 secondary outcomes
Homeostasis Model of Assessment of Insulin Resistance
Time frame: 4 weeks
Peripheral blood pressure
Time frame: 4 weeks
Central blood pressure
Time frame: 4 weeks
Total cholesterol
Time frame: 4 weeks
Pulse Wave Velocity
Time frame: 4 weeks
Augmentation index
Time frame: 4 weeks
Diet quality measured by the Healthy Eating Index 2010
Time frame: 4 weeks
Change in fecal short chain fatty acid levels
Time frame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Change in microbiome composition
Time frame: Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
LDL cholesterol
Time frame: 4 weeks
HDL cholesterol
Time frame: 4 weeks
Triglycerides
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
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-based side dish and Refined grain-based in people with Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Penn State University at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 18 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2023.