Effect of Naringenin and Beta Carotene on Energy Expenditure

Not Applicable

Completed

• Conditions: Energy Expenditure; Safety Issues; Glucose Metabolism
• Interventions: Dietary Supplement: naringenin and beta carotene

• Registration Number: NCT04697355
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

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 Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Status Verified: 2021-04
• Study Start: 2021-04-19
• Primary Completion: 2021-06-16
• Study Completion: 2021-08-02
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Fasting blood glucose < 200mg/dL

Exclusion Criteria

• Known allergy to citrus fruits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naringenin + Beta carotene	naringenin and beta carotene	Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day

Primary Outcome Measures

Name	Time	Method
Energy expenditure	Five hours	Ventilated hood
Incidence of Treatment-Emergent Adverse Events	Eight weeks	Adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States