Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lifestyle Modification and Potato Consumption

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by USDA Grand Forks Human Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
Susan Raatz, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01771926
First received: March 29, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention
Obesity
Other: potatoes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lifestyle Modification and Potato Consumption

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Glucose Tolerance [ Time Frame: Days 0, 14, 28, 42, 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight Loss [ Time Frame: Days 0, 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Functional Fitness [ Time Frame: Days 0 and 57 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771926

Contacts
Contact: Susan K Raatz, PhD, RD 701-795-8396 susan.raatz@ars.usda.gov

Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58203
Contact: Angela Scheett, MPH, RD    701-795-8386    angela.scheett@ars.usda.gov   
Principal Investigator: Susan Raatz, PhD, RD         
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Susan K Raatz, PhD, MPH, RD USDA GFHNRC
  More Information

Additional Information:
No publications provided

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
Study First Received: March 29, 2012
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014