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Clinical Trials/NCT03190993
NCT03190993
Completed
Not Applicable

The Diet Composition and Energy Balance Pilot Study

Pennington Biomedical Research Center1 site in 1 country20 target enrollmentJuly 21, 2017
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ConditionsNutritional Physiological PhenomenaObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutritional Physiological Phenomena
Sponsor
Pennington Biomedical Research Center
Enrollment
20
Locations
1
Primary Endpoint
Change From Baseline in Body Weight
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2017
End Date
June 21, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Apolzan

Assistant Professor

Pennington Biomedical Research Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change From Baseline in Body Weight

Time Frame: 1 month

Change from baseline in body weight at 1 month

Study Sites (1)

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