- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689738
Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety
July 23, 2019 updated by: Midwest Center for Metabolic and Cardiovascular Research
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33487
- Cathy Maki
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Potato condition
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.
|
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.
|
Active Comparator: Control condition
Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.
|
Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 300 minutes - measured at the end of each treatment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Up to 300 minutes - measured at the end of each treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2018
Primary Completion (Actual)
February 20, 2019
Study Completion (Actual)
February 20, 2019
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
September 27, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-1802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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