Menstrual Cycle Hormones and Eating Behavior

Completed

• Conditions: Food Preference; Dietary Habits

• Registration Number: NCT01407692
• Lead Sponsor: USDA, Western Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eating behavior	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Eating behavior, including types of foods preferred, wanting/desire for specific foods, and perception of hunger will be measured using four questionnaires; Eating inventory: to assess dietary restraint, Stanford Brief Physical Activity Questionnaire, Food craving questionnaire, Eating behavior and attitudes questionnaire

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	To determine if the phase of the menstrual cycle affects insulin sensitivity, we will measure plasma insulin, glucose and non-esterified fatty acids (NEFA).
Serum lipid profile changes	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Blood samples will be analyzed for lipids and lipoproteins, including apoproteins A1, B, C-II, C-III, and E.
Estradiol	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Estradiol measured in serum in relation to appetite variables
progesterone	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Progesterone measured in serum in relation to appetite variables
Endocannabinoid profile	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Endocannabinoid profile measured in serum to assess appetite
Urinary c-peptide	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	The level of urinary C-peptide and creatinine will be measured in a 24-hour urine collection.
Leptin	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Leptin measured in serum to assess appetite
Dehydroepiandrosterone (DHEA)	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	Dehydroepiandrosterone measured in serum in relation to appetite variables
Sex Hormone Binding Globulin (SHBG)	At follicular (day 11) and luteal (day 26) phase of menstrual cycle	SHBG measured in serum in relation to appetite variables

Trial Locations

Locations (1)

USDA, ARS, Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States