NCT04697355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

August 9, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

January 4, 2021

Last Update Submit

August 2, 2021

Conditions

Energy ExpenditureSafety IssuesGlucose Metabolism

Outcome Measures

Primary Outcomes (2)

  • Energy expenditure

    Ventilated hood

    Five hours

  • Incidence of Treatment-Emergent Adverse Events

    Adverse events

    Eight weeks

Secondary Outcomes (3)

  • Glucose metabolism

    Three hours

  • Blood pressure

    24 hours

  • Body weight

    16 weeks

Study Arms (1)

Naringenin + Beta carotene

EXPERIMENTAL

Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day

Dietary Supplement: naringenin and beta carotene

Interventions

naringenin and beta caroteneDIETARY_SUPPLEMENT

Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks

Naringenin + Beta carotene

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting blood glucose \< 200mg/dL

You may not qualify if:

  • Known allergy to citrus fruits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related 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.

    PMID: 31670603BACKGROUND

MeSH Terms

Interventions

naringeninbeta Carotene

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Frank L Greenway, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Case study in a single human subject
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

April 19, 2021

Primary Completion

June 16, 2021

Study Completion

August 2, 2021

Last Updated

August 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)