Insulin SensitivityNCT03689738
Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety
A study testing Potato (Resistant Starch) and CHO-matched (Low-fiber, RS-free) in people with Insulin Sensitivity and Lipid Metabolism, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this study is to assess whether intake of baked and then chilled potatoes over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and satiety, and decrease hunger and free fatty… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Lipid Metabolism, Resistant Starch
- What is being tested?
- Potato (Resistant Starch) and CHO-matched (Low-fiber, RS-free)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 20 Feb 2019
- 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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male or female, 18-74 years of age, inclusive.
- Subject has a BMI of ≥27.0-39.99 kg/m2 at visit 1.
- Subject has a waist circumference ≥40 in for men and ≥35 in for women at visit 1.
- Subject has a rating of 7 to 10 on the Vein Access Scale at visit 1 (Appendix 2).
- Subject is willing to maintain a stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial, except for the substitution of the study foods.
- Subject is willing to consume the study foods provided throughout the duration of the study.
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- Subject has no plans to change smoking habits or other nicotine use during the study period and is willing to refrain from nicotine use for 1 h prior to and during all test visits.
- Subject is willing to refrain from alcohol and vigorous physical activity 24 hours prior to test days (visits 2, 3, 4 and 5).
- Subject is judged by the Investigator to be in general good health on the basis of medical history.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Who cannot join
- Subject has a fasting capillary glucose of ≥126 mg/dL and/or a HbA1C ≥6.5 % based on the capillary blood draw at visit 1.
- Subject has a history or presence of atherosclerotic cardiovascular disease, chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), or clinically important endocrine (including type 1 or type 2 diabetes mellitus), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer.
- Subject has experienced a change in body weight of ±4.5 kg (10 lbs) over the 3 months prior to visit 1.
- Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study foods.
- Subject has uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP
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- 100 mm Hg) at visit 1.
- Subject has unstable use of any antihypertensive medication within 4 weeks prior to visit 1. Unstable use is defined as initiation or dose alteration.
- Subject has used any of the following medications within 4 weeks of visit 1:
- With the exception of the stable use of statins (defined as no initiation or dose alteration within 4 weeks of visit 1) any medications intended to alter the lipid profile, including but not limited to: bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
- Medications known to significantly influence carbohydrate metabolism, including, but not limited to, adrenergic receptor blockers, diuretics, and/or hypoglycemic medications.
- Weight-loss drugs (including over-the-counter medications) or weight loss programs.
- Systemic corticosteroid drugs.
- Subject has used any of the following foods or dietary supplements within 2 weeks of visit 1:
- Food/supplements known to influence lipid metabolism, including, but not limited to, omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d (or others at the discretion of the Investigator).
- Irregular or inconsistent use of Metamucil® or other viscous fiber-containing supplements (consistent, daily use up to 1 tsp of a viscous-fiber supplement is acceptable).
- Subject has used antibiotics within 5 days of any clinic visit: For those with an active infection and/or using antibiotics, subjects must wait at least 5 d after the infection resolves or antibiotic use is complete. The test period will be extended for study completion in these cases.
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Subject has extreme dietary habits (e.g. very low CHO diet, vegan, etc.).
- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Subject is a habitual breakfast skipper (defined as skipping breakfast ≥4 times per week).
- Subject has a current or recent history (past 12 months), or strong potential, for drug or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
- Subject has been exposed to any non-registered drug product within 30 days of visit 1.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety in Men and Women at Risk for Type 2 Diabetes
The objective of this study is to assess whether intake of baked and then chilled potatoes over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and satiety, and decrease hunger and free fatty acid (FFA) levels in overweight or obese men and women at risk for metabolic syndrome and diabetes mellitus.
Read the detailed description
This randomized, two-period crossover study will include one screening/baseline visit (visit 1) and two 24-h treatment periods (treatment period 1: visits 2 and 3 and treatment period 2: visits 4 and 5). A minimum 7-d washout will occur between the treatment periods.
- Conditions
- Insulin Sensitivity, Lipid Metabolism, Resistant Starch, Potato
- Being tested
- Potato (Resistant Starch), CHO-matched (Low-fiber, RS-free)
- Keywords
- Resistant Starch, Free Fatty Acids, Potato, Insulin sensitivity, Lipid Metabolism
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato (Resistant Starch)Other
Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g resistant starch (RS) per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS.
CHO-matched (Low-fiber, RS-free)Other
Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.
| Study group | Role | What they receive |
|---|---|---|
| Potato condition | Experimental | Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g RS per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS. Receives: Other: Potato (Resistant Starch) |
| Control condition | Active comparator | Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack. Receives: Other: CHO-matched (Low-fiber, RS-free) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Matsuda insulin sensitivity index (MISI)
Difference in the Matsuda insulin sensitivity index (MISI) between the Potato and Control conditions following a breakfast meal tolerance test (MTT) completed on day 2 of each treatment period.
Measured: Up to 300 minutes - measured at the end of each treatment period
Secondary outcomes (7)
Change in the total area under the curve (AUC) for insulin
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the total area under the curve (AUC) from pre-breakfast intake to 5-h post-breakfast intake for insulin.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the total area under the curve (AUC) for glucose
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the total area under the curve (AUC) from pre-breakfast intake to 5-h post-breakfast intake for glucose.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the incremental AUC (iAUC) for insulin
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the incremental AUC (iAUC) from pre-breakfast intake to 5-h post-breakfast intake for insulin and glucose.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the incremental AUC (iAUC) for glucose
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the incremental AUC (iAUC) from pre-breakfast intake to 5-h post-breakfast intake for insulin and glucose.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the AUC for FFA
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the AUC for FFA from 0-3 h, 0-5 h, and 3-5 h postprandially.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the net iAUC for fullness, hunger, desire to eat and prospective food consumption
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the net iAUC from pre-breakfast intake to 5-h post-breakfast intake for fullness, hunger, desire to eat and prospective food consumption.
Measured: Up to 300 minutes - measured at the end of each treatment period
Change in the total AUC for breath hydrogen
Differences between the Potato and Control conditions following a breakfast MTT completed on day 2 of each treatment period in the total AUC for breath hydrogen from 0-5 h post-breakfast intake.
Measured: Up to 300 minutes - measured at the end of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start24 Sep 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689738
- Sponsor's protocol ID
- MB-1802
- Status last verified
- Jul 2019
- First submitted
- 27 Sep 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety in Men and Women at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03689738
- Acronym / sponsor ID
- MB-1802
- Conditions
- Insulin Sensitivity, Lipid Metabolism, Resistant Starch, Potato
- Keywords
- Resistant Starch, Free Fatty Acids, Potato, Insulin sensitivity, Lipid Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 28 Sep 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.
The objective of this study is to assess whether intake of baked and then chilled potatoes over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and satiety, and decrease hunger and free fatty acid (FFA) levels in overweight or obese men and women at risk for metabolic syndrome and diabetes mellitus.
Detailed description
This randomized, two-period crossover study will include one screening/baseline visit (visit 1) and two 24-h treatment periods (treatment period 1: visits 2 and 3 and treatment period 2: visits 4 and 5). A minimum 7-d washout will occur between the treatment periods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potato condition | Experimental | Other: Potato (Resistant Starch)Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g RS per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS. |
| Control condition | Active comparator | Other: CHO-matched (Low-fiber, RS-free)Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is a male or female, 18-74 years of age, inclusive.
- Subject has a BMI of ≥27.0-39.99 kg/m2 at visit 1.
- Subject has a waist circumference ≥40 in for men and ≥35 in for women at visit 1.
- Subject has a rating of 7 to 10 on the Vein Access Scale at visit 1 (Appendix 2).
- Subject is willing to maintain a stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial, except for the substitution of the study foods.
Key exclusion criteria (24 listed)
- Subject has a fasting capillary glucose of ≥126 mg/dL and/or a HbA1C ≥6.5 % based on the capillary blood draw at visit 1.
- Subject has a history or presence of atherosclerotic cardiovascular disease, chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), or clinically important endocrine (including type 1 or type 2 diabetes mellitus), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer.
- Subject has experienced a change in body weight of ±4.5 kg (10 lbs) over the 3 months prior to visit 1.
- Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study foods.
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 (Resistant Starch)Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g resistant starch (RS) per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS. | Other | Potato condition |
| CHO-matched (Low-fiber, RS-free)Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack. | Other | Control condition |
Primary outcome
Change in the Matsuda insulin sensitivity index (MISI)
Time frame: Up to 300 minutes - measured at the end of each treatment period
Difference in the Matsuda insulin sensitivity index (MISI) between the Potato and Control conditions following a breakfast meal tolerance test (MTT) completed on day 2 of each treatment period.
7 secondary outcomes
Change in the total area under the curve (AUC) for insulin
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the total area under the curve (AUC) for glucose
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the incremental AUC (iAUC) for insulin
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the incremental AUC (iAUC) for glucose
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the AUC for FFA
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the net iAUC for fullness, hunger, desire to eat and prospective food consumption
Time frame: Up to 300 minutes - measured at the end of each treatment period
Change in the total AUC for breath hydrogen
Time frame: Up to 300 minutes - measured at the end of each treatment period
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 25 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Resistant Starch) and CHO-matched (Low-fiber, RS-free) in people with Insulin Sensitivity and Lipid Metabolism, run by Midwest Center for Metabolic and Cardiovascular Research 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 10 inclusion and 24 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 25 Jul 2019. 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?
Change in the Matsuda insulin sensitivity index (MISI) (time frame: Up to 300 minutes - measured at the end of each treatment period). 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 25 Jul 2019.