Time-restricted Eating in Peri- and Postmenopausal Women

Last updated: January 3, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Menopause

Obesity

Treatment

Time-restricted eating

Clinical Study ID

NCT06188598
2022P002288
  • Ages 40-58
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion 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 cardiovasculardisease risk-enhancing factors per American College of Cardiology/American HeartAssociation guidelines
  • Normal renal and hepatic function
  • Perimenopausal women, a negative pregnancy test

Exclusion

Exclusion Criteria: Dietary factors:

  • Diagnosis, or strong clinical suspicion, of eating disorders, including but notlimited to, anorexia nervosa, bulimia nervosa, binge eating disorder
  • Concurrent dietary intervention or modification unrelated to study procedures Psychiatric factors:
  • Current major depressive episode
  • Suicidal ideation
  • Lifetime history of bipolar disorder, psychosis, or other serious mental healthproblem
  • Current alcohol/substance use disorder Medical factors:
  • 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 andmedication 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 recommendedtiming of medication ingestion with food intake. Lifestyle and other factors:
  • 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 Adherence factors:

-Inability to adhere to study procedures completed between screening and randomizationvisits Off-Study Criteria:

  • 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 thatmight interfere with study procedures.
  • Significant deviation from study protocol or protocol violation
  • Inability to adhere to time-restricted eating window

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Time-restricted eating
Phase:
Study Start date:
December 21, 2022
Estimated Completion Date:
December 21, 2024

Study Description

This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating (control) on metabolic health and body composition in recently postmenopausal women with untreated dyslipidemia. Following a 1-week baseline assessment, participants will be randomized to either a TRE or unrestricted control diet schedule (1-to-1 ratio) for 8 weeks. At baseline and weeks 4 and 8 of the intervention, daily eating and sleep patterns will be assessed for one week, followed by collection of fasting lipids and metabolic labs, body weight and vital signs; questionnaires assessing sleep and mood health, actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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