Effect of Naringenin and Beta Carotene on Energy Expenditure

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04697355
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Energy Expenditure; Safety Issues; Glucose Metabolism	Dietary Supplement: naringenin and beta carotene	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Case study in a single human subjectCase study in a single human subject
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene
• Actual Study Start Date: Apr 19, 2021
• Actual Primary Completion Date: Jun 16, 2021
• Actual Study Completion Date: Aug 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Energy expenditure [Five hours]

   Ventilated hood

2. Incidence of Treatment-Emergent Adverse Events [Eight weeks]

   Adverse events

Secondary Outcome Measures

1. Glucose metabolism [Three hours]

   Oral glucose tolerance test with insulin

2. Blood pressure [24 hours]

   Ambulatory

3. Body weight [16 weeks]

   Measurement of body weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Fasting blood glucose < 200mg/dL

Exclusion Criteria:

• Known allergy to citrus fruits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Frank Greenway, Chief Medical Officer, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT04697355
• Other Study ID Numbers: IRB FWA 00006218
• First Posted: Jan 6, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Beta Carotene; Naringenin; Carotenoids

Study Results

No Results Posted as of Aug 9, 2021