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Completed

NCT Number: NCT03518515

Potato Consumption and Energy Balance

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White potato (french fries)

Other

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

Other

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

Other

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.

Primary outcomes

  1. Change in fat mass

    Time frame: baseline and study completion (30 days)

    Determined by dual-energy X-ray absorptiometry.

Secondary outcomes

  1. Change in body weight

    Time frame: baseline and study completion (30 day)

  2. Change in fasting glucose

    Time frame: baseline and study completion (30 day)

  3. Change in fasting insulin

    Time frame: baseline and study completion (30 day)

  4. Change in HbA1c

    Time frame: baseline and study completion (30 day)

  5. Change in caloric Intake

    Time frame: baseline and study completion (30 days)

    Dietary recall by 3 day food record.

  6. Meal Tolerance Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Alliance for Potato Research and Education
  • Indiana University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2018
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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