time-restricted eating in peri- and postmenopausal women

Conditions: Dyslipidemias; Obesity; Menopause

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.

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.

Eligibility criteria:
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