RECRUITING

Time-restricted Eating in Peri- and Postmenopausal Women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-12-21

Study Completion:2024-12-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06188598

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.

Ages Eligible for Study:40 Years to 58 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Leilah K Grant, PhD

CONTACT

6175257118

lgrant@bwh.harvard.edu

Principal Investigator

Leilah K Grant, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-21

Study Completion Date2024-12-21

Study Record Updates

Study Start Date2022-12-21

Study Completion Date2024-12-21

Terms related to this study

Additional Relevant MeSH Terms

Dyslipidemias
Obesity
Menopause