Potato Research for Enhancing Metabolic Outcomes

NCT04203238 | Completed Results

• 1 other identifier: PBRC 2019-029
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The potato is a nutritious food that comprises approximately 30% of total vegetable intake in the United States (US). Consumption of pulses in the US is low but its contribution to health is frequently promoted. However, in the US diet, potatoes contribute as much dietary fiber, far more potassium, and a host of similar nutrients as pulses. When prepared to enhance its slowly digested starch content, potatoes produce a moderate glycemic response. In encouraging a shift towards plant-based foods and sustainable diets, the potato can partially replace meat in meat dishes to enhance the overall quality of the diet and reduce meat intake to recommended levels.

Conditions

Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• Glycemic Response to the Diet

  Change in area under the curve for blood glucose (mg/dL/min) concentration in response to the diet. Negative values are considered a better outcome.

  Baseline and 8 weeks

Secondary Outcomes (5)

• Insulin Response to the Diet

  Baseline and 8 weeks

• Cholesterol Response to the Diet

  Baseline and 8 weeks

• Triglyceride Response to the Diet

  Baseline and 8 weeks

• LDL Particle Size Response to the Diet

  Baseline and 8 weeks

• hsCRP Response to the Diet

  Baseline and 8 weeks

Study Arms (2)

Potatoes Lean Meat (PLM)

EXPERIMENTAL

The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.

Other: Reduced Meat High Potato Diet

Lean Meat Pulses (LMP)

EXPERIMENTAL

The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses. The diet is designed to provide six or less ounces of meat/day which is consistent with the DASH diet.

Other: Reduced Meat High Pulses Diet

Interventions

Reduced Meat High Potato Diet OTHER

The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.

Potatoes Lean Meat (PLM)

Reduced Meat High Pulses Diet OTHER

The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.

Lean Meat Pulses (LMP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults from 18 - 60 years of age
• Body mass index between 25 and 40 kg/m2
• No evidence of diabetes (fasting blood sugar \<126 mg/dL).
• HOMA-IR \> 2
• Willing to consume the study foods and refrain from eating other foods for eight weeks.

You may not qualify if:

• Have type 1 or type 2 diabetes currently being treated by medication.
• Are being treated with medications that have a significant effect on insulin resistance, obesity, serum lipids, and metabolic rate, or medications that significantly increase body weight such as certain antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators.
• Current pregnancy or breastfeeding.
• Women of childbearing potential who are not using an effective method of birth control (i.e., barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), are not surgically sterilized (including tubal ligation and hysterectomy), or not at least two years postmenopausal. All women of childbearing potential will have a pregnancy test performed prior to starting the study treatment in each cohort. If a subject becomes pregnant during the study, they will be dropped from the study.
• Have clinically significant abnormal laboratory markers (as determined by the medical investigator).
• Have contraindications to participation in a diet intervention.
• Are unable to provide a baseline blood sample.
• Have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the foods being tested in the study (determined by the investigative team).

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Rebello CJ, Beyl RA, Greenway FL, Atteberry KC, Hoddy KK, Kirwan JP. Low-Energy Dense Potato- and Bean-Based Diets Reduce Body Weight and Insulin Resistance: A Randomized, Feeding, Equivalence Trial. J Med Food. 2022 Dec;25(12):1155-1163. doi: 10.1089/jmf.2022.0072. Epub 2022 Nov 11.

  PMID: 36367708 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Candida Rebello
• Organization: Pennington Biomedical Research Center

Candida.Rebello@pbrc.edu

2257633159

Study Officials

• John Kirwan, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and care providers will be blinded to randomization and treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Randomized parallel design

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: December 18, 2019
• Study Start: September 4, 2019
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)