Trial Summary
What is the purpose of this trial?This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
Is Time-Restricted Eating a promising treatment for postmenopausal women with metabolic syndrome?Yes, Time-Restricted Eating (TRE) is a promising treatment. It can help reduce weight, lower blood pressure, and improve heart health by managing when you eat. This approach can be added to regular medical care to improve overall health in people with metabolic syndrome.12567
What safety data exists for time-restricted eating in treating metabolic syndrome?The studies reviewed indicate that time-restricted eating (TRE) is a promising intervention for improving cardiometabolic health in individuals with metabolic syndrome. In a trial involving 19 participants with metabolic syndrome, TRE was found to improve health outcomes when combined with standard medical care, including statin and antihypertensive use. While the focus of these studies is on efficacy, they suggest that TRE can be safely integrated with existing treatments for metabolic syndrome.13678
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are on hormone therapy or taking ADHD medications.
What data supports the idea that Time-Restricted Eating for Metabolic Syndrome in Postmenopausal Women is an effective treatment?The available research shows that Time-Restricted Eating (TRE) can be an effective treatment for metabolic syndrome in postmenopausal women. One study found that a 10-hour TRE schedule over 12 weeks helped reduce weight, lower blood pressure, and decrease harmful fats in the blood for people with metabolic syndrome. Another study highlighted that TRE could improve body weight, reduce abdominal obesity, and lower blood pressure without changing the amount or type of food eaten. These improvements were observed even when participants were already on standard medical treatments like statins and blood pressure medications. Overall, TRE appears to be a promising lifestyle change that can work alongside traditional medical treatments to improve health outcomes for those with metabolic syndrome.12457
Eligibility Criteria
This trial is for postmenopausal women aged 45-65 who are prediabetic or show at least two signs of metabolic syndrome and lead a sedentary lifestyle. It's not suitable for those with significant sleep disruptions, psychiatric disorders, heart disease, uncontrolled sleep issues, heavy alcohol use, eating disorders, diabetes, extreme sleeping patterns or those doing shift work.Inclusion Criteria
I am a woman who has gone through menopause.
I am between 45 and 65 years old.
I am a woman who has gone through menopause.
Exclusion Criteria
I have heart disease.
I have a sleep disorder that is not under control.
Treatment Details
The study is testing if eating within a set time frame each day (time-restricted feeding) can improve health markers like blood sugar control and body weight in metabolically-unhealthy postmenopausal women. Participants will be randomly assigned to one of two groups to compare the effects.
2Treatment groups
Experimental Treatment
Active Control
Group I: Time-Restricted Feeding (TRF) GroupExperimental Treatment1 Intervention
Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.
Group II: ControlActive Control1 Intervention
Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who is running the clinical trial?
Julie PendergastLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. [2021]In animal models, time-restricted feeding (TRF) can prevent and reverse aspects of metabolic diseases. Time-restricted eating (TRE) in human pilot studies reduces the risks of metabolic diseases in otherwise healthy individuals. However, patients with diagnosed metabolic syndrome often undergo pharmacotherapy, and it has never been tested whether TRE can act synergistically with pharmacotherapy in animal models or humans. In a single-arm, paired-sample trial, 19 participants with metabolic syndrome and a baseline mean daily eating window of ≥14 h, the majority of whom were on a statin and/or antihypertensive therapy, underwent 10 h of TRE (all dietary intake within a consistent self-selected 10 h window) for 12 weeks. We found this TRE intervention improves cardiometabolic health for patients with metabolic syndrome receiving standard medical care including high rates of statin and anti-hypertensive use. TRE is a potentially powerful lifestyle intervention that can be added to standard medical practice to treat metabolic syndrome. VIDEO ABSTRACT.
Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. [2021]Eating out of phase with daily circadian rhythms induces metabolic desynchrony in peripheral metabolic organs and may increase chronic disease risk. Time-restricted eating (TRE) is a dietary approach that consolidates all calorie intake to 6- to 10-h periods during the active phase of the day, without necessarily altering diet quality and quantity. TRE reduces body weight, improves glucose tolerance, protects from hepatosteatosis, increases metabolic flexibility, reduces atherogenic lipids and blood pressure, and improves gut function and cardiometabolic health in preclinical studies. This review discusses the importance of meal timing on the circadian system, the metabolic health benefits of TRE in preclinical models and humans, the possible mechanisms of action, the challenges we face in implementing TRE in humans, and the possible consequences of delaying initiation of TRE.
Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose.
Time-Restricted Eating and Metabolic Syndrome: Current Status and Future Perspectives. [2021]Metabolic syndrome (MetS) occurs in ~30% of adults and is associated with increased risk of cardiovascular disease and diabetes mellitus. MetS reflects the clustering of individual cardiometabolic risk factors including central obesity, elevated fasting plasma glucose, dyslipidemia, and elevated blood pressure. Erratic eating patterns such as eating over a prolonged period per day and irregular meal timing are common in patients with MetS. Misalignment between daily rhythms of food intake and circadian timing system can contribute to circadian rhythm disruption which results in abnormal metabolic regulation and adversely impacts cardiometabolic health. Novel approaches which aim at restoring robust circadian rhythms through modification of timing and duration of daily eating represent a promising strategy for patients with MetS. Restricting eating period during a day (time-restricted eating, TRE) can aid in mitigating circadian disruption and improving cardiometabolic outcomes. Previous pilot TRE study of patients with MetS showed the feasibility of TRE and improvements in body weight and fat, abdominal obesity, atherogenic lipids, and blood pressure, which were observed despite no overt attempt to change diet quantity and quality or physical activity. The present article aims at giving an overview of TRE human studies of individuals with MetS or its components, summarizing current clinical evidence for improving cardiometabolic health through TRE intervention in these populations, and presenting future perspectives for an implementation of TRE to treat and prevent MetS. Previous TRE trials laid the groundwork and indicate a need for further clinical research including large-scale controlled trials to determine TRE efficacy for reducing long-term cardiometabolic risk, providing tools for sustained lifestyle changes and, ultimately, improving overall health in individuals with MetS.
Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. [2021]Metabolic syndrome (MetS) and erratic eating patterns are associated with circadian rhythm disruption which contributes to an increased cardiometabolic risks. Restricting eating period (time-restricted eating, TRE) can restore robust circadian rhythms and improve cardiometabolic health. We describe a protocol of the Time-Restricted Eating on Metabolic and Neuroendocrine homeostasis, Inflammation, and Oxidative Stress (TREMNIOS) pilot clinical trial in Polish adult patients with MetS and eating period of ≥14 h/day. The study aims to test the feasibility of TRE intervention and methodology for evaluating its efficacy for improving metabolic, neuroendocrine, inflammatory, oxidative stress and cardiac biomarkers, and daily rhythms of behavior for such population. Participants will apply 10-h TRE over a 12-week monitored intervention followed by a 12-week self-directed intervention. Changes in eating window, body weight and composition, biomarkers, and rhythms of behavior will be evaluated. Dietary intake, sleep, activity and wellbeing will be monitored with the myCircadianClock application and questionnaires. Adherence to TRE defined as the proportion of days recorded with app during the monitored intervention in which participants satisfied 10-h TRE is the primary outcome. TREMNIOS will also provide an exploratory framework to depict post-TRE changes in cardiometabolic outcomes and behavior rhythms. This protocol extends previous TRE-related protocols by targeting European population with diagnosed MetS and including long-term intervention, validated tools for monitoring dietary intake and adherence, and comprehensive range of biomarkers. TREMNIOS trial will lay the groundwork for a large-scale randomized controlled trial to determine TRE efficacy for improving cardiometabolic health in MetS population.
Time restricted eating as a weight loss intervention in adults with obesity. [2021]Time-restricted eating (TRE) is a weight management approach in which food is consumed only within a specific period each day. The simplicity of this approach is appealing, but its efficacy is not known. The aim of this pilot cohort study was to assess adherence to TRE and its effects on weight and lipid profile.
Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. [2023]Time-restricted eating (TRE) is a promising dietary intervention for weight loss and improvement of cardiometabolic risk factors. We aim to provide a critical review of blood pressure outcomes reported in clinical TRE studies in adults with metabolic syndrome, in the context of the proposed mechanisms that underlie the relationship between timing of eating and blood pressure.
Metabolic and behavioral effects of time-restricted eating in women with overweight or obesity: Preliminary findings from a randomized study. [2023]The aim of this study was to evaluate the effects of 8 wk of time-restricted eating (TRE) along with a caloric restriction on metabolic profile, metabolic rate, symptoms of mood, and eating disorders and weight loss in women with overweight or obesity.