Potato Consumption and Energy Balance

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03518515
• Collaborator: Alliance for Potato Research and Education (Other), Indiana University (Other)
• Enrollment: 180
• Location: 1
• Arms: 3
• Actual Duration (Months): 19.5
• Patients Per Site Per Month: 9.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: White potato (french fries); Other: White potato (French fries), +seasoning; Other: Almond	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial
• Actual Study Start Date: Aug 2, 2018
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: White potato (French fries) Participants will be asked to consume 1 serving of French fries each day for 30 days.	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.
Experimental: White potato (French fries), +seasoning Participants will be asked to consume 1 serving of French fries with added seasoning each day for 30 days.	Other: 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.
Active Comparator: Almond Participants will be asked to consume 1 serving of almonds (calorie-matched to other arms) day for 30 days.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Change in fat mass [baseline and study completion (30 days)]

   Determined by dual-energy X-ray absorptiometry.

Secondary Outcome Measures

1. Change in body weight [baseline and study completion (30 day)]

2. Change in fasting glucose [baseline and study completion (30 day)]

3. Change in fasting insulin [baseline and study completion (30 day)]

4. Change in HbA1c [baseline and study completion (30 day)]

5. Change in caloric Intake [baseline and study completion (30 days)]

   Dietary recall by 3 day food record.

6. Meal Tolerance Test [Study Completion (30 day)]

   A subset of subjects from each diet group will participate in a meal-based tolerance test with the study food items.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Alliance for Potato Research and Education
• Indiana University

Investigators

• Principal Investigator: Daniel Smith, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel L. Smith, Jr., Co-Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03518515
• Other Study ID Numbers: IRB-300001187
• First Posted: May 8, 2018
• Last Update Posted: May 8, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel L. Smith, Jr., Co-Principal Investigator, University of Alabama at Birmingham: nutrition intervention; potato consumption; energy balance

Study Results

No Results Posted as of May 8, 2020