Effect of Naringenin and Beta Carotene on Energy Expenditure

August 2, 2021 updated by: Frank Greenway, Pennington Biomedical Research Center

Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene

This study is designed to test the effects of the combination of naringenin (from an extract of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single human subject.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The subject will be treated for 8 weeks with the combination of naringenin + beta carotene.

We will conduct the following assessments before the treatment and at the end of eight weeks.

  1. Resting metabolic rate
  2. Oral glucose tolerance test with glucose and insulin
  3. Ambulatory blood pressure
  4. Recording of adverse events
  5. Body weight

Study Type

Interventional

Enrollment (Actual)

1

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fasting blood glucose < 200mg/dL

Exclusion Criteria:

  • Known allergy to citrus fruits

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naringenin + Beta carotene
Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day
Dietary supplement: naringenin and beta carotene
Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy expenditure
Time Frame: Five hours
Ventilated hood
Five hours
Incidence of Treatment-Emergent Adverse Events
Time Frame: Eight weeks
Adverse events
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 16 weeks
Measurement of body weight
16 weeks
Glucose metabolism
Time Frame: Three hours
Oral glucose tolerance test with insulin
Three hours
Blood pressure
Time Frame: 24 hours
Ambulatory
24 hours

Collaborators and Investigators

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

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Frank L Greenway, M.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 19, 2021

Primary Completion (Actual)

June 16, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB FWA 00006218

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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