NCT01771926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

March 29, 2012

Last Update Submit

August 1, 2018

Conditions

Keywords

resistant starchlifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Glucose Tolerance

    Days 0, 14, 28, 42, 56

Secondary Outcomes (2)

  • Weight Loss

    Days 0, 14, 28, 42, 56

  • Functional Fitness

    Days 0 and 57

Study Arms (3)

High Resistant Starch Potatoes

EXPERIMENTAL

Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.

Other: potatoes

Low Resistant Starch Potatoes

EXPERIMENTAL

Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.

Other: potatoes

Other Carbohydrate Source

PLACEBO COMPARATOR

Subjects will receive 1 serving daily for 8 weeks during the weight loss group sessions.

Other: other carbohydrate

Interventions

Daily intake of assigned treatment for 8 weeks

High Resistant Starch PotatoesLow Resistant Starch Potatoes

Daily intake of assigned treatment for 8 weeks

Other Carbohydrate Source

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan K Raatz, PhD, MPH, RD

    USDA GFHNRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

January 18, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Study Completion

June 1, 2016

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations