Time-restricted Eating in Peri- and Postmenopausal Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188598
• Other study ID #: 2022P002288
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 21, 2024

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: Leilah K Grant, PhD
• Phone: 6175257118
• Email: lgrant[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 21, 2024
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 58 Years

Eligibility

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 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 Exclusion Criteria:

Dietary factors:

• 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

Psychiatric factors:

• Current major depressive episode
• Suicidal ideation
• Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
• 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 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.

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 randomization visits

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

Related Conditions & MeSH terms

• Dyslipidemias
• Menopause
• Obesity

Intervention

Behavioral:
• Time-restricted eating
Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time-course of triglyceride levels across 8 weeks	The time course of triglyceride (mg/dL) levels measured pre- mid- and post-intervention	Baseline (week 0), mid- (week 4) and post-intervention (week 8)
Primary	Change in fasting triglyceride levels	Pre- to post-intervention change in fasting triglyceride levels (mg/dL)	Baseline (week 0) and post-intervention (week 8)
Primary	Change in visceral adiposity	Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in body weight	Pre- to post-intervention change in body weight (kg)	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in high-density lipoprotein cholesterol (HDL-C)	Pre- to post-intervention change in HDL-C (mg/dL)	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in low-density lipoprotein cholesterol (LDL-C)	Pre- to post-intervention change in LDL-C (mg/dL)	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in systolic blood pressure	Pre- to post-intervention change in systolic blood pressure (mmHg)	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in sleep quality	Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance.	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in depressive symptoms	Change in depressive symptoms as measure by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 score ranges from 0-24 with higher scores indicating greater depressive symptoms.	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in positive and negative affect	Change in positive and negative affect as measure by the Positive and Negative Affect Schedule. The PANAS Positive and Negative scores range from 10-50 with higher scores indicating greater postive and negative affect, respectively.	Baseline (week 0) and post-intervention (week 8)
Secondary	Change in sleep duration	Change in sleep duration based on the average of self-reported sleep duration over 1 week	Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Secondary	Change in sleep efficiency	Change in sleep efficiency based on the average of self-reported sleep efficiency over 1 week. Sleep efficiency to be calculated as total sleep time/ time in bed.	Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)