NCT01186393

Brief Summary

The purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

August 19, 2010

Last Update Submit

May 14, 2015

Conditions

Obesity

Keywords

Weight LossPotatoesDietary MeetingsGlycemic Control

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    12 Weeks

Secondary Outcomes (3)

  • Glucose tolerance

    12 Weeks

  • Body composition

    12 weeks

  • Blood Pressure

    12 weeks

Study Arms (3)

Control

EXPERIMENTAL

Arm includes dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Control diet will be prescribed for weight maintenance.

Behavioral: Control

Low Glycemic Index

EXPERIMENTAL

Diets will be energy-restricted (\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.

Behavioral: Low Glycemic Index

High Glycemic Index

EXPERIMENTAL

Diets will be energy-restricted (\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on High Glycemic Index foods.

Behavioral: High Glycemic Index

Interventions

ControlBEHAVIORAL

Dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance.

Also known as: No energy reduction
Control
Low Glycemic IndexBEHAVIORAL

Diets will be energy-restricted (\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.

Also known as: Low glycemic index reduced energy
Low Glycemic Index
High Glycemic IndexBEHAVIORAL

Diets will be energy-restricted (\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.

Also known as: High glycemic index reduced energy
High Glycemic Index

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • ≥ 18 years of age who have a body mass index (BMI) of 25 to 35 kg/m2 (inclusive).

You may not qualify if:

  • Total cholesterol (TC) not greater than 300 mg/dL,
  • Fasting triglyceride not greater than 300 mg/dL ,
  • LDL cholesterol (LDL-C) not greater than 180 mg/dL,
  • Smokers
  • Female subjects who are pregnant or lactating
  • Subjects taking any medications that would interfere with outcomes of the study
  • Subjects with unusual dietary habits (eg., pica)
  • Subjects who are actively losing weight or trying to lose weight
  • Subjects who are addicted to drugs or alcohol or who are \< 1 y in recovery program
  • Subjects who present with significant psychiatric or neurological disturbances
  • Subjects with known allergy or intolerance to potato products
  • Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension ( 140/90 mm Hg), chronic lung, renal or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)

Davis, California, 95616, United States

Location

VA Hospital, Mather

Mather, California, 95655, United States

Location

Related Publications (1)

  • Randolph JM, Edirisinghe I, Masoni AM, Kappagoda T, Burton-Freeman B. Potatoes, glycemic index, and weight loss in free-living individuals: practical implications. J Am Coll Nutr. 2014;33(5):375-84. doi: 10.1080/07315724.2013.875441. Epub 2014 Oct 10.

    PMID: 25302575RESULT

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Britt Burton-Freeman, Ph.D

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • C. Tissa Kappagoda, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 23, 2010

Study Start

May 1, 2007

Primary Completion

November 1, 2010

Study Completion

March 1, 2014

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations

US(2)