Clinical trial NCT01186393: STUDY: Effects of Potatoes in a Weight Loss Program
Official title: CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Potatoes
Dietary Meetings
Glycemic Control
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The study will examine the effect of including potatoes as part of a calorie restricted diet designed to induce weight loss and improve glycemic control in overweight subjects.

This is a randomized, treatment-controlled, 3-arm, parallel study. The 3 arms of the study will include dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Two diets will be energy-restricted (\~ 500 kcal deficit /d) for weight loss and the control diet will be prescribed for weight maintenance. The two energy-restricted diets will include further manipulation, such that, one dietary plan will be a high glycemic index (GI) diet and the other a low glycemic index diet.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight Loss
timeFrame: 12 Weeks
Secondary outcomes:
measure: Glucose tolerance
timeFrame: 12 Weeks
measure: Body composition
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
state: California
city: Mather
country: United States
facility: VA Hospital, Mather
state: California
Study officials:
affiliation: University of California, Davis
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: C. Tissa Kappagoda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.