The DEB Pilot Study

NCT03190993 | Completed Results

• 1 other identifier: 6218
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutritional Physiological Phenomena; Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight

  Change from baseline in body weight at 1 month

  1 month

Study Arms (2)

Sugar Sweetened Solid Treatment

ACTIVE COMPARATOR

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

Sugar Sweetened Beverage Treatment

ACTIVE COMPARATOR

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

Other: Sugar Sweetened Beverage Treatment

Interventions

Sugar Sweetened Solid Treatment OTHER

Consume Sugar Sweetened Solid Treatment (product) daily.

Sugar Sweetened Solid Treatment

Sugar Sweetened Beverage Treatment OTHER

Consume Sugar Sweetened Beverage Treatment (product) daily.

Also known as: SSB Treatment

Sugar Sweetened Beverage Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 20 - 40

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Martin, Corby, K., M.D.: collaborator
• Owen T. Carmichael: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Apolzan
• Organization: Pennington Biomedical Research Center

john.apolzan@pbrc.edu

225-763-2827

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: July 21, 2017
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: October 19, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)