The DEB Pilot Study (DEB Pilot)

October 13, 2020 updated by: John Apolzan, Pennington Biomedical Research Center

The Diet Composition and Energy Balance 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sugar Sweetened Solid Treatment
A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.
Other: Sugar Sweetened Solid Treatment
Consume Sugar Sweetened Solid Treatment (product) daily.
Active Comparator: Sugar Sweetened Beverage Treatment
20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.
Other: Sugar Sweetened Beverage Treatment
Consume Sugar Sweetened Beverage Treatment (product) daily.
Other Names:
  • SSB Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight
Time Frame: 1 month
Change from baseline in body weight at 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Corby K. Martin
Owen T. Carmichael

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2017

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

June 21, 2018

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 6218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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