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AzTrials

Dietary HabitsFL-84NCT01407692

Menstrual Cycle Hormones and Eating Behavior

An observational study of Dietary Habits and Food Preference, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Dietary Habits, Food Preference
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 2011to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Healthy, premenopausal women.

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USDA, ARS, Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
menstrual cycle, estrogen
Medical subject headings
Feeding Behavior, Food Preferences

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (9)

  1. 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).

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

  2. Serum lipid profile changes

    Blood samples will be analyzed for lipids and lipoproteins, including apoproteins A1, B, C-II, C-III, and E.

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

  3. Urinary c-peptide

    The level of urinary C-peptide and creatinine will be measured in a 24-hour urine collection.

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

  4. Estradiol

    Estradiol measured in serum in relation to appetite variables

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

  5. progesterone

    Progesterone measured in serum in relation to appetite variables

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

  6. Dehydroepiandrosterone (DHEA)

    Dehydroepiandrosterone measured in serum in relation to appetite variables

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

  7. Sex Hormone Binding Globulin (SHBG)

    SHBG measured in serum in relation to appetite variables

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

  8. Endocannabinoid profile

    Endocannabinoid profile measured in serum to assess appetite

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

  9. Leptin

    Leptin measured in serum to assess appetite

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407692
Sponsor's protocol ID
WHNRC 221594-1
Acronym
FL-84
Status last verified
Dec 2017
First submitted
26 Jul 2011
Last updated
5 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30031087

  • 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.

    PubMed 27527001

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Habits and Food Preference, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating behavior (time frame: At follicular (day 11) and luteal (day 26) phase of menstrual cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407692, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.

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