Energy Expenditure, Glucose Metabolism, Safety Issues
Conditions
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
Interventions
DIETARY_SUPPLEMENTnaringenin and beta carotene
Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Case study in a single human subject
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Fasting blood glucose \< 200mg/dL
Exclusion criteria
* Known allergy to citrus fruits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy expenditure | Five hours | Ventilated hood |
| Incidence of Treatment-Emergent Adverse Events | Eight weeks | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism | Three hours | Oral glucose tolerance test with insulin |
| Blood pressure | 24 hours | Ambulatory |
| Body weight | 16 weeks | Measurement of body weight |
Countries
United States
Outcome results
None listed