Clinical trial NCT03518515: Potato Consumption and Energy Balance
Official title: Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: nutrition intervention
potato consumption
energy balance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alliance for Potato Research and Education
name: Indiana University
First posted: 2018-05-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.

Detailed description: This is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato French fry, 3) standard white potato French fry with potential glycemia-modulating spice/seasoning mix added.

Free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. Body composition (via dual energy x-ray absorptiometry; DXA), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.

Eligibility criteria: Inclusion Criteria:

* 18- 50 years old
* Body mass index (BMI) 20- 35
* No dietary restrictions or allergies
* Weight stable
* Access to camera through smartphone, computer or tablet

Exclusion Criteria:

* Pregnancy or anticipating pregnancy or lactation
* Nut or food allergy
* Diagnosed diabetes (Type 1 or 2)
* History of weight control surgery (bariatric or liposuction)
* Consumes \>1 serving of potatoes daily before enrollment
* Weight loss or gain \>5% within past 6 months
* Medical conditions or medications that would prevent the ability to comply with treatment assignment and/or affect energy balance
* Dependence on others for food procurement or preparation

Primary outcomes:
measure: Change in fat mass
timeFrame: baseline and study completion (30 days)
Secondary outcomes:
measure: Change in body weight
timeFrame: baseline and study completion (30 day)
measure: Change in fasting glucose
timeFrame: baseline and study completion (30 day)
measure: Change in fasting insulin
timeFrame: baseline and study completion (30 day)
measure: Change in HbA1c
timeFrame: baseline and study completion (30 day)
measure: Change in caloric Intake
timeFrame: baseline and study completion (30 days)
measure: Meal Tolerance Test
timeFrame: Study Completion (30 day)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Daniel Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith DL, Hanson RL, Dickinson SL, Chen X, Goss AM, Cleek JB, Garvey WT, Allison DB. French-fried potato consumption and energy balance: a randomized controlled trial. Am J Clin Nutr. 2022 Jun 7;115(6):1626-1636. doi: 10.1093/ajcn/nqac045.