NCT03518515

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

April 24, 2018

Last Update Submit

May 7, 2020

Conditions

Keywords

nutrition interventionpotato consumptionenergy balance

Outcome Measures

Primary Outcomes (1)

  • Change in fat mass

    Determined by dual-energy X-ray absorptiometry.

    baseline and study completion (30 days)

Secondary Outcomes (6)

  • Change in body weight

    baseline and study completion (30 day)

  • Change in fasting glucose

    baseline and study completion (30 day)

  • Change in fasting insulin

    baseline and study completion (30 day)

  • Change in HbA1c

    baseline and study completion (30 day)

  • Change in caloric Intake

    baseline and study completion (30 days)

  • +1 more secondary outcomes

Study Arms (3)

White potato (French fries)

EXPERIMENTAL

Participants will be asked to consume 1 serving of French fries each day for 30 days.

Other: White potato (french fries)

White potato (French fries), +seasoning

EXPERIMENTAL

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

Almond

ACTIVE COMPARATOR

Participants will be asked to consume 1 serving of almonds (calorie-matched to other arms) day for 30 days.

Other: Almond

Interventions

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)

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.

White potato (French fries), +seasoning
AlmondOTHER

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.

Almond

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Smith, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 8, 2018

Study Start

August 2, 2018

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations