Skip to main content
OpenTrials
Completed

NCT Number: NCT04697355

Effect of Naringenin and Beta Carotene on Energy Expenditure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Energy Expenditure Glucose Metabolism Safety Issues

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

  • Resting metabolic rate
  • Oral glucose tolerance test with glucose and insulin
  • Ambulatory blood pressure
  • Recording of adverse events
  • Body weight

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fasting blood glucose < 200mg/dL

Exclusion criteria

  • Known allergy to citrus fruits

Treatment and study plan

naringenin and beta carotene

Dietary Supplement

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

Primary outcomes

  1. Energy expenditure

    Time frame: Five hours

    Ventilated hood

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: Eight weeks

    Adverse events

Secondary outcomes

  1. Glucose metabolism

    Time frame: Three hours

    Oral glucose tolerance test with insulin

  2. Blood pressure

    Time frame: 24 hours

    Ambulatory

  3. Body weight

    Time frame: 16 weeks

    Measurement of body weight

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.