The DEB Pilot Study

NCT ID: NCT03190993

Last Updated: 2020-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-06-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nutritional Physiological Phenomena Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sugar Sweetened Solid Treatment

Intervention Type OTHER

Consume Sugar Sweetened Solid Treatment (product) daily.

Sugar Sweetened Beverage Treatment

20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder.

Group Type ACTIVE_COMPARATOR

Sugar Sweetened Beverage Treatment

Intervention Type OTHER

Consume Sugar Sweetened Beverage Treatment (product) daily.

Interventions

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Sugar Sweetened Solid Treatment

Consume Sugar Sweetened Solid Treatment (product) daily.

Intervention Type OTHER

Sugar Sweetened Beverage Treatment

Consume Sugar Sweetened Beverage Treatment (product) daily.

Intervention Type OTHER

Other Intervention Names

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SSB Treatment

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Martin, Corby, K., M.D.

INDIV

Sponsor Role collaborator

Owen T. Carmichael

UNKNOWN

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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John Apolzan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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6218

Identifier Type: -

Identifier Source: org_study_id

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