The DEB Pilot Study

Obesity Clinical Trial

— DEB Pilot  

Official title:

The Diet Composition and Energy Balance Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190993
• Other study ID #: 6218
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: October 2020
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Physiological Phenomena
• Obesity

Intervention

Other:
• Sugar Sweetened Solid Treatment
Consume Sugar Sweetened Solid Treatment (product) daily.
• Sugar Sweetened Beverage Treatment
Consume Sugar Sweetened Beverage Treatment (product) daily.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Corby K. Martin, Owen T. Carmichael

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Body Weight	Change from baseline in body weight at 1 month	1 month