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Completed

NCT Number: NCT01407692

Menstrual Cycle Hormones and Eating Behavior

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior Food Preference Food Preferences

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Eating behavior

    Time frame: 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 outcomes

  1. Insulin sensitivity

    Time frame: 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).

  2. Serum lipid profile changes

    Time frame: 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.

  3. Urinary c-peptide

    Time frame: 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.

  4. Estradiol

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    Estradiol measured in serum in relation to appetite variables

  5. progesterone

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    Progesterone measured in serum in relation to appetite variables

  6. Dehydroepiandrosterone (DHEA)

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    Dehydroepiandrosterone measured in serum in relation to appetite variables

  7. Sex Hormone Binding Globulin (SHBG)

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    SHBG measured in serum in relation to appetite variables

  8. Endocannabinoid profile

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    Endocannabinoid profile measured in serum to assess appetite

  9. Leptin

    Time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle

    Leptin measured in serum to assess appetite

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Official study title

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

Acronym: FL-84

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2011
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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