Menstrual Cycle Hormones and Eating Behavior

NCT ID: NCT01407692

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Habits Food Preference

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

menstrual cycle estrogen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nancy Keim, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, ARS, Western Human Nutrition Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30031087 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27527001 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ars.usda.gov/pacific-west-area/davis-ca/whnrc/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WHNRC 221594-1

Identifier Type: -

Identifier Source: org_study_id