Lifestyle Modification and Potato Consumption

August 1, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. We will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Study Type

Interventional

Enrollment (Actual)

107

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

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • Grand Forks Human Nutrition Research Center

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between 20-65 years of age.
  • Overweight or obese (BMI 25 - 39.9 Kg/m2)
  • Impaired Glucose Tolerance: fasting glucose between 100-125 mg/dL
  • Willingness to comply with the demands of the experimental protocol
  • Sedentary lifestyle

Exclusion Criteria

  • Major medical condition
  • Smokers
  • Unable to perform moderate exercise
  • Use of medications that alter glucose or lipid metabolism
  • Pregnant or lactating

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Resistant Starch Potatoes
Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.
Other: potatoes
Daily intake of assigned treatment for 8 weeks
Experimental: Low Resistant Starch Potatoes
Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.
Other: potatoes
Daily intake of assigned treatment for 8 weeks
Placebo Comparator: Other Carbohydrate Source
Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.
Other: other carbohydrate
Daily intake of assigned treatment for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose Tolerance
Time Frame: Days 0, 14, 28, 42, 56
Days 0, 14, 28, 42, 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: Days 0, 14, 28, 42, 56
Days 0, 14, 28, 42, 56
Functional Fitness
Time Frame: Days 0 and 57
Days 0 and 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Susan K Raatz, PhD, MPH, RD, USDA GFHNRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

February 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GFHNRC024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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