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Lifestyle Modification and Potato Consumption

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ClinicalTrials.gov Identifier: NCT01771926
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Susan Raatz, USDA Grand Forks Human Nutrition Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: potatoes Other: other carbohydrate Not Applicable

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  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Modification and Potato Consumption
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2016

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




Primary Outcome Measures :
  1. Glucose Tolerance [ Time Frame: Days 0, 14, 28, 42, 56 ]

Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: Days 0, 14, 28, 42, 56 ]
  2. Functional Fitness [ Time Frame: Days 0 and 57 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771926


Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Susan K Raatz, PhD, MPH, RD USDA GFHNRC

Additional Information:
Responsible Party: Susan Raatz, PhD, RD, Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01771926     History of Changes
Other Study ID Numbers: GFHNRC024
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Susan Raatz, USDA Grand Forks Human Nutrition Research Center:
resistant starch
lifestyle intervention