NCT00838409

Brief Summary

This study will be a cross-sectional study. The primary aim of this study is to compare the relationship between neurological function, metabolic measures and health-related behaviors between normal weight and overweight/obese perimenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

3.1 years

First QC Date

February 4, 2009

Last Update Submit

September 13, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women.

    3 months

Study Arms (1)

1

Eligibility Criteria

Age42 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Body Mass index 18-39.9 kg/m2
  • Peri-menopausal status by self-report

You may not qualify if:

  • Pregnant
  • Plan to become pregnant
  • Breastfeeding in the last 6 months
  • Multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
  • Menopause confirmed
  • Unable to refrain from smoking for five hours (self-report)
  • Unable to refrain from consuming alcohol for two days (self-report)
  • Weight change \> 10 lbs in the preceding 6 months
  • Chronic corticosteroid use
  • Oral corticosteroids used more than twice in the last 12 months
  • Hormonal contraceptives
  • Antipsychotic, anti-anxiety and anti-depressant medications
  • Beta adrenergic blockers
  • Sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide
  • Immunosuppressants
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples will be kept for future research purposes.

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Laugero, PhD

    USDA, ARS, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 6, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations