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Completed

NCT Number: NCT03190993

The DEB Pilot Study

The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

Dose: Participants are to consume 1 unit per day of the study product.

Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 20 - 40

Exclusion criteria

  • Diabetes (Type 1 or 2)
  • Prediabetes
  • Active cancer
  • Serious digestive disorders
  • Other conditions that affect metabolism or body weight
  • Uncontrolled Thyroid disorder (controlled = 6 months of medication)
  • Unable to consume study foods
  • Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)
  • Pregnancy
  • Intentions of becoming pregnant in the next 2 months
  • Women who have undergone partial hysterectomy with intact ovary function
  • Current or past alcohol or drug abuse problem
  • Allergy or intolerance to study product ingredients.
  • Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol

Treatment and study plan

Sugar Sweetened Solid Treatment

Other

Consume Sugar Sweetened Solid Treatment (product) daily.

Sugar Sweetened Beverage Treatment

Other

Consume Sugar Sweetened Beverage Treatment (product) daily.

Other names: SSB Treatment

Primary outcomes

  1. Change From Baseline in Body Weight

    Time frame: 1 month

    Change from baseline in body weight at 1 month

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Martin, Corby, K., M.D.
  • Owen T. Carmichael

Registry information

Official study title

The Diet Composition and Energy Balance Pilot Study

Acronym: DEB Pilot

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2017
Registry last updated
Oct 19, 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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