Potato Consumption and Energy Balance

Obesity Clinical Trial

Official title:

Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518515
• Other study ID #: IRB-300001187
• Status: Completed
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: March 18, 2020

Study information

• Verified date: May 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• White potato (french fries)
If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) each day for 30 days as a part of their usual dietary intake. French fries will be portioned and provided to participants.
• White potato (French fries), +seasoning
If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) with added potential glycemia modifying seasoning mix each day for 30 days as a part of their usual dietary intake. French fries and seasoning will be portioned and provided to participants.
• Almond
If randomized to this group, participants will be asked to consume 1 serving of almonds that is calorically-matched to the French fries (~300 kcal) serving in the other arms each day for 30 days as a part of their usual dietary intake. Almonds will be portioned and provided to participants.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alliance for Potato Research and Education, Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fat mass	Determined by dual-energy X-ray absorptiometry.	baseline and study completion (30 days)
Secondary	Change in body weight		baseline and study completion (30 day)
Secondary	Change in fasting glucose		baseline and study completion (30 day)
Secondary	Change in fasting insulin		baseline and study completion (30 day)
Secondary	Change in HbA1c		baseline and study completion (30 day)
Secondary	Change in caloric Intake	Dietary recall by 3 day food record.	baseline and study completion (30 days)
Secondary	Meal Tolerance Test	A subset of subjects from each diet group will participate in a meal-based tolerance test with the study food items.	Study Completion (30 day)