Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety

NCT03689738 | Completed

• 1 other identifier: MB-1802
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 acid (FFA) levels in overweight or obese men and women at risk for metabolic syndrome and diabetes mellitus.

Conditions

Insulin Sensitivity; Lipid Metabolism; Resistant Starch; Potato

Keywords

Resistant Starch; Free Fatty Acids; Potato; Insulin sensitivity; Lipid Metabolism

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 300 minutes - measured at the end of each treatment period

• Change in the total area under the curve (AUC) for glucose

  Up to 300 minutes - measured at the end of each treatment period

• Change in the incremental AUC (iAUC) for insulin

  Up to 300 minutes - measured at the end of each treatment period

• Change in the incremental AUC (iAUC) for glucose

  Up to 300 minutes - measured at the end of each treatment period

• Change in the AUC for FFA

  Up to 300 minutes - measured at the end of each treatment period

Study Arms (2)

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.

Other: Potato (Resistant Starch)

Control condition

ACTIVE COMPARATOR

Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.

Other: CHO-matched (Low-fiber, RS-free)

Interventions

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.

Potato condition

CHO-matched (Low-fiber, RS-free) OTHER

Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.

Control condition

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Cathy Maki

Boca Raton, Florida, 33487, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: September 24, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

US (1)