Dyslipidemias, Menopause, Obesity
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALTime-restricted eating
Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blood tests and assays, DXA scans, body weight, vitals, etc. are performed by assessors blinded to the condition and aims of the study.
Intervention model description
Randomized on 1:1 bases to time-restricted eating or unrestricted eating
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 58 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visceral adiposity | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan |
| Change in fasting triglyceride levels | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in fasting triglyceride levels (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in high-density lipoprotein cholesterol (HDL-C) | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in HDL-C (mg/dL) |
| Change in low-density lipoprotein cholesterol (LDL-C) | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in LDL-C (mg/dL) |
| Change in systolic blood pressure | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in systolic blood pressure (mmHg) |
| Change in sleep quality | Baseline (week 0) and post-intervention (week 8) | 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. |
| Change in depressive symptoms | Baseline (week 0) and post-intervention (week 8) | 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. |
| Change in positive and negative affect | Baseline (week 0) and post-intervention (week 8) | 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. |
| Change in sleep duration | Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) | Change in sleep duration based on the average of self-reported sleep duration over 1 week |
| Change in sleep efficiency | Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) | 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. |
| Change in body weight | Baseline (week 0) and post-intervention (week 8) | Pre- to post-intervention change in body weight (kg) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time-course of triglyceride levels across 8 weeks | Baseline (week 0), mid- (week 4) and post-intervention (week 8) | The time course of triglyceride (mg/dL) levels measured pre- mid- and post-intervention |
Countries
United States
Contacts
Primary ContactLeilah K Grant, PhD
Outcome results
None listed