Clinical trial NCT01407692: Menstrual Cycle Hormones and Eating Behavior
Official title: Effect of Menstrual Cycle Hormone Changes on Eating Behavior and Nutrient Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Food Preference
Keywords: menstrual cycle
estrogen
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-08-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, premenopausal women.

Brief summary: The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus unopposed estrogen phase) affects eating behavior, including types of foods preferred, wanting/desire for specific foods, and perception of hunger.

Detailed description: This is an observational study to investigate the effect of endogenous estrogen (E2) and progesterone (P4) levels on eating behavior and energy-yielding nutrient metabolism. Eating behavior will be assessed during a complete menstrual cycle during the first month of the study. Participants will track the follicular and luteal phases of their menstrual cycle using urinary leuteinizing hormone (LH) kits, they will record information about their food intake, eating behaviors, and appetite in their home environments, and they will complete two laboratory test days: one test day scheduled during their follicular phase, and one test day scheduled during their luteal phase.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index between 20-30 Kg/m2
* regular menstrual cycles
* sedentary lifestyle (physical activity not more than 30 minutes per day three times a week)

Exclusion Criteria:

* Fasting blood sugar greater than 110 mg/dL
* Systolic Blood Pressure greater than 140 mmHg
* Diastolic Blood Pressure greater than 90 mmHg
* Fasting triglycerides greater than 120 mg/dL
* Documented or self-reported chronic disorders such as arthritis, or other inflammatory diseases
* Women who are Post-menopausal or Peri-menopausal
* Pre-menopausal women who are pregnant, uni/multiparous, taking oral contraceptives, or who have menstrual cycles lasting less than 20 days or greater than 45 days, polycystic ovary syndrome (PCOS), amenorrhea, eumenorrhoea, or polymenorrhoea.

Primary outcomes:
measure: Eating behavior
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Serum lipid profile changes
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Urinary c-peptide
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Estradiol
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: progesterone
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Dehydroepiandrosterone (DHEA)
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Sex Hormone Binding Globulin (SHBG)
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Endocannabinoid profile
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
measure: Leptin
timeFrame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Nancy Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krishnan S, Agrawal K, Tryon RR, Welch LC, Horn WF, Newman JW, Keim NL. Structural equation modeling of food craving across the menstrual cycle using behavioral, neuroendocrine, and metabolic factors. Physiol Behav. 2018 Oct 15;195:28-36. doi: 10.1016/j.physbeh.2018.07.011. Epub 2018 Jul 18.
citation: Krishnan S, Tryon RR, Horn WF, Welch L, Keim NL. Estradiol, SHBG and leptin interplay with food craving and intake across the menstrual cycle. Physiol Behav. 2016 Oct 15;165:304-12. doi: 10.1016/j.physbeh.2016.08.010. Epub 2016 Aug 12.