Menstrual Cycle Hormones and Eating Behavior (FL-84)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01407692
First received: July 26, 2011
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition
Dietary Habits
Food Preference

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Menstrual Cycle Hormone Changes on Eating Behavior and Nutrient Metabolism

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Eating behavior [ Time Frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle ] [ Designated as safety issue: No ]
    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:
  • Insulin sensitivity [ Time Frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle ] [ Designated as safety issue: No ]
    To determine if the phase of the menstrual cycle affects insulin sensitivity, we will measure plasma insulin, glucose, leptin and non-esterified fatty acids (NEFA).

  • Serum lipid profile changes [ Time Frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle ] [ Designated as safety issue: No ]
    Blood samples will be analyzed for lipids and lipoproteins, including apoproteins A1, B, CII, CIII, and E.

  • Urinary c-peptide [ Time Frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle ] [ Designated as safety issue: No ]
    The level of urinary C-peptide and creatinine will be measured in a 24-hour urine collection.


Biospecimen Retention:   Samples Without DNA

Serum, plasma and urine samples may be retained for future testing.


Enrollment: 24
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy, premenopausal women.

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, PCOS, amenorrhea, eumenorrhoea, or polymenorrhoea.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407692

Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Nancy Keim, PhD USDA, ARS, Western Human Nutrition Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01407692     History of Changes
Other Study ID Numbers: WHNRC 221594-1
Study First Received: July 26, 2011
Last Updated: February 7, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
menstrual cycle
estrogen

ClinicalTrials.gov processed this record on September 16, 2014