Healthy
Conditions
Keywords
Fasting, Gut hormones, Inflammatory Cytokines
Brief summary
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.
Interventions
DRUGLeptin administration
Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.
BEHAVIORALFasting
Complete fasting, save for water and multivitamin, for four days.
Sponsors
Massachusetts Institute of Technology
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* female age 18-35 * BMI 20-26.0 * eumenorrheic with normal FSH, TSH, Prolactin * Hgb \> 12 g/dL, normal creatinine * normal puberty and development * negative pregnancy test. In addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital.
Exclusion criteria
* medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function * medications known to affect neuroendocrine function * prior history of eating disorder or significant menstrual irregularities * subjects who have a known hypersensitivity to E. Coli derived protein. * subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease * history of anaphylaxis or anaphylactoid like reactions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hormone levels change from baseline. | Change from baseline after 4 days of intervention. | Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion. |
Secondary
| Measure | Time frame |
|---|---|
| Levels of inflammatory cytokines change from baseline. | Change from baseline after 4 days of intervention. |
Countries
United States
Outcome results
None listed