Menstrual Cycle Hormones and Eating Behavior

Dietary Habits Clinical Trial

— FL-84  

Official title:

Effect of Menstrual Cycle Hormone Changes on Eating Behavior and Nutrient Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407692
• Other study ID #: WHNRC 221594-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: December 1, 2017
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2017
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits
• Food Preference

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   United States Department of Agriculture, ARS, Western Human Nutrition Research Center