Effect of Naringenin and Beta Carotene on Energy Expenditure

Overview

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.

Full Title of Study: “Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 16, 2021

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Naringenin + Beta carotene
    • Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Fasting blood glucose < 200mg/dL Exclusion Criteria:

  • Known allergy to citrus fruits

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pennington Biomedical Research Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Frank Greenway, Chief Medical Officer – Pennington Biomedical Research Center
  • Overall Official(s)
    • Frank L Greenway, M.D., Principal Investigator, Pennington Biomedical Research Center

References

Murugesan N, Woodard K, Ramaraju R, Greenway FL, Coulter AA, Rebello CJ. Naringenin Increases Insulin Sensitivity and Metabolic Rate: A Case Study. J Med Food. 2020 Mar;23(3):343-348. doi: 10.1089/jmf.2019.0216. Epub 2019 Oct 31.

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