Time-restricted Eating in Peri- and Postmenopausal Women

Description

The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia.

Conditions

Dyslipidemias, Obesity, Menopause

Study Overview

Study Details

Study overview

The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia.

Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women

Time-restricted Eating in Peri- and Postmenopausal Women

Condition
Dyslipidemias
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy women aged 40-58 years
  • * Perimenopausal or recently postmenopausal, \>1 year and \<5 years
  • * BMI \> 30 kg/m2
  • * Dyslipidemic, defined as the presence of one or more lipid-based cardiovascular disease risk-enhancing factors per American College of Cardiology/American Heart Association guidelines
  • * Normal renal and hepatic function
  • * Perimenopausal women, a negative pregnancy test
  • * Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder
  • * Concurrent dietary intervention or modification unrelated to study procedures
  • * Current major depressive episode
  • * Suicidal ideation
  • * Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
  • * Current alcohol/substance use disorder
  • * Use of lipid-lowering or lipid-enhancing medications
  • * Use of systemic hormonal (estrogens and/or progestin) therapies
  • * Use of weight loss medications or supplements
  • * Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
  • * Previous weight loss surgery
  • * Abnormal vital signs at screening visit
  • * Body weight \> 350 pounds, per DXA scan limits
  • * Malignancy within past 2 years
  • * Major surgery within past 3 months
  • * Medical instability considered to interfere with study procedures
  • * Contraindications to DXA scanning
  • * Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
  • * Undergoing treatment for cancer
  • * Use of medications for which time-restricted eating would interfere with recommended timing of medication ingestion with food intake.
  • * Irregular sleep/wake schedule
  • * Shiftwork
  • * Recent travel across 2 or more time zones
  • * Recent change in exercise habits
  • * Work or social schedules that would impede ability to adhere to study protocol
  • * Initiation of new medications for lipid management, weight loss, hormonal medications, or other medications that may cause changes in weight or lipid levels
  • * Development of any significant medical problem
  • * Enrollment in another clinical trial involving study procedures or medications that might interfere with study procedures.
  • * Significant deviation from study protocol or protocol violation
  • * Inability to adhere to time-restricted eating window

Ages Eligible for Study

40 Years to 58 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Brigham and Women's Hospital,

Leilah K Grant, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2024-12-21