Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.
  • Phase

  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    leptin ...
  • Study Participants

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.
Study Started
Nov 30
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Dec 10

Drug Leptin administration

Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.

Behavioral Fasting

Complete fasting, save for water and multivitamin, for four days.

Fasting alone Placebo Comparator

Fasting plus leptin Active Comparator


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.
No Results Posted