Energy ExpenditureNCT04697355
Effect of Naringenin and Beta Carotene on Energy Expenditure
A study testing naringenin and beta carotene in people with Energy Expenditure and Safety Issues, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Energy Expenditure, Safety Issues, Glucose Metabolism
- What is being tested?
- naringenin and beta carotene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting blood glucose < 200mg/dL
Who cannot join
- Known allergy to citrus fruits
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene
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.
Read the 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.
- Resting metabolic rate
- Oral glucose tolerance test with glucose and insulin
- Ambulatory blood pressure
- Recording of adverse events
- Body weight
- Conditions
- Energy Expenditure, Safety Issues, Glucose Metabolism
- Being tested
- naringenin and beta carotene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Naringenin + Beta carotene | Experimental | Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day Receives: Dietary Supplement: naringenin and beta carotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Ventilated hood
Measured: Five hours
Incidence of Treatment-Emergent Adverse Events
Adverse events
Measured: Eight weeks
Secondary outcomes (3)
Glucose metabolism
Oral glucose tolerance test with insulin
Measured: Three hours
Blood pressure
Ambulatory
Measured: 24 hours
Body weight
Measurement of body weight
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start19 Apr 2021
- Primary completion16 Jun 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case study in a single human subject
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L Greenway, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697355
- Sponsor's protocol ID
- IRB FWA 00006218
- Status last verified
- Apr 2021
- First submitted
- 4 Jan 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31670603
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene
- ClinicalTrials.gov ID
- NCT04697355
- Acronym / sponsor ID
- IRB FWA 00006218
- Conditions
- Energy Expenditure, Safety Issues, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Resting metabolic rate
- Oral glucose tolerance test with glucose and insulin
- Ambulatory blood pressure
- Recording of adverse events
- Body weight
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case study in a single human subject
| Arm | Type | Receives |
|---|---|---|
| Naringenin + Beta carotene | Experimental | Dietary Supplement: naringenin and beta caroteneSubject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting blood glucose < 200mg/dL
Key exclusion criteria (1 listed)
- Known allergy to citrus fruits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naringenin and beta caroteneSubject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks | Dietary supplement | Naringenin + Beta carotene |
Primary outcome
Energy expenditure
Time frame: Five hours
Ventilated hood
Incidence of Treatment-Emergent Adverse Events
Time frame: Eight weeks
Adverse events
3 secondary outcomes
Glucose metabolism
Time frame: Three hours
Blood pressure
Time frame: 24 hours
Body weight
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 31670603Murugesan 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.
- Individual participant dataSharing planned: No
Related trials for Energy Expenditure
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Recruiting
Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Healthy Adult
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank L Greenway, M.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naringenin and beta carotene in people with Energy Expenditure and Safety Issues, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: Five hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.