Effect of Naringenin and Beta Carotene on Energy Expenditure

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697355
• Other study ID #: IRB FWA 00006218
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: August 2, 2021

Study information

• Verified date: April 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fasting blood glucose < 200mg/dL

Exclusion Criteria:

• Known allergy to citrus fruits

Related Conditions & MeSH terms

• Energy Expenditure
• Glucose Metabolism
• Safety Issues

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure	Ventilated hood	Five hours
Primary	Incidence of Treatment-Emergent Adverse Events	Adverse events	Eight weeks
Secondary	Glucose metabolism	Oral glucose tolerance test with insulin	Three hours
Secondary	Blood pressure	Ambulatory	24 hours
Secondary	Body weight	Measurement of body weight	16 weeks