Time-Restricted Feeding for Cardiovascular Disease Risk Factors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Diabetes medications, Weight loss drugs
Disqualifiers: Diabetes, Cancer, Cardiovascular disease, others
Trial Summary
What is the purpose of this trial?This trial is testing whether eating only during certain hours of the day (time-restricted eating) can help people with prediabetes control their blood sugar, lose weight, and improve heart health. Participants will follow different eating schedules for a few months to see which is most effective. Time-restricted eating (TRE) is an emerging dietary intervention for weight loss and metabolic health, with various studies investigating its effects on body weight, fat oxidation, and heart health.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on diabetes medication or any medication that affects blood sugar or blood pressure rhythms.
What data supports the effectiveness of this treatment for cardiovascular disease risk factors?
Research suggests that time-restricted eating (TRE) can lead to mild weight loss and may improve cardiovascular health by lowering blood pressure and insulin resistance, which are risk factors for heart disease.
12345Is time-restricted eating safe for humans?
Time-restricted eating (TRE) is generally considered safe for humans, as it involves eating within a specific time window each day. Studies have shown it can be followed without major safety concerns, although individual experiences may vary.
34678How is time-restricted feeding different from other treatments for cardiovascular disease risk factors?
Time-restricted feeding (TRF) is unique because it involves eating only during a specific time window each day, which may help improve cardiovascular health by aligning eating patterns with the body's natural circadian rhythms. Unlike traditional treatments that might focus on medication or continuous calorie restriction, TRF emphasizes the timing of food intake, potentially offering a simpler and more natural approach to managing cardiovascular risk factors.
3491011Eligibility Criteria
This trial is for adults aged 30-65 with a BMI of 27-43 who regularly wake up between 5-8 am and are prediabetic. It's not suitable for those with psychiatric conditions, significant diseases, recent weight fluctuations, or on certain medications affecting glucose or blood pressure.Inclusion Criteria
I am between 30 and 65 years old.
My blood sugar levels indicate I am prediabetic.
You need to wake up at a regular time between 5 and 8 in the morning.
+1 more
Exclusion Criteria
I have lost or gained more than 3 kg in the last 3 months.
My long-term medication dose hasn't changed in the last 3 months.
Pregnant or breastfeeding
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are assigned to one of three time-restricted eating schedules for 8 weeks: Early TRE, Mid-day TRE, or Control Schedule. All food is provided and matched between groups.
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if eating within specific hours (Early TRF: ~8 am-3 pm; Mid-day TRF: ~1 pm - 8 pm) versus a control schedule (~8 am - 8 pm) affects blood sugar control, blood pressure, and cardiovascular risk factors over a period of 10 weeks.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Mid-day TREExperimental Treatment1 Intervention
Group II: Early TREExperimental Treatment1 Intervention
Group III: Control SchedulePlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Bibliometric and visual analysis of time-restricted eating. [2022]An increasing number of studies have shown the effects of time-restricted eating (TRE) on metabolic diseases and cardiovascular diseases associated with obesity. However, no bibliometric analyses were conducted in this field systematically. In our study, we aimed to visualize the publications about TRE to determine the frontiers and hotspots and then provide references and guidance for further studies. Publications about TRE were exported from the Web of Science Core Collection (WOSCC) database. VOSviewer 1.6.16 was adopted to perform the bibliometric analysis. In our study, a total of 414 publications with 298 articles and 116 reviews were included. The publications in this field showed an upward trend from 2016. A total of 2016 authors contributed to this field. The most productive authors were Satchidananda Panda, Krista A Varady and Emily NC Manoogian. All publications were distributed from about 624 organizations from 49 Countries/Regions. The leading institutions were the Salk Institute for Biological Studies, the University of California San Diego and the University of Alabama at Birmingham, and the most productive countries were the United States, the People's Republic of China and Japan. All publications were from 182 journals, and the most productive journals were Nutrients, Frontiers in Nutrition and Cell Metabolism. The first highest cited reference with 991 citations was published in Cell Metabolism, and authored by Satchidananda Panda et al. There were four indicating research directions, and the keywords of the green cluster were time-restricted feeding, metabolism, circadian clock, and circadian rhythm. The keywords of the blue cluster were obesity, health, diet, and food intake. The keywords of the red cluster were intermittent fasting, weight loss, caloric restriction, and time-restricted eating. The keywords of the yellow cluster were insulin resistance, metabolic disease, cardiovascular disease, and caloric intake. The main research hotspots in the TRE field were TRE and circadian rhythm, TRE and obesity, TRE and metabolic disease, and TRE and cardiovascular disease. TRE represents new directions to evaluate the effects of the timing of eating on different diseases, especially obesity, Type 2 diabetes mellitus and cardiovascular disease. Previous studies have generated impressive data on the effects of TRE on metabolic diseases and cardiovascular diseases associated with obesity. More high-quality studies are needed to assess the mechanism and efficacy of TRE in a wide range of populations and diseases.
Early time-restricted eating affects weight, metabolic health, mood, and sleep in adherent completers: A secondary analysis. [2023]Data are mixed on whether intermittent fasting improves weight loss and cardiometabolic health. Here, the effects of time-restricted eating (TRE) in participants who consistently adhered ≥5 d/wk every week were analyzed.
Time-Restricted Eating to Improve Cardiovascular Health. [2021]Time-restricted eating (TRE) is a form of intermittent fasting that involves confining the eating window to 4-10 h and fasting for the remaining hours of the day. The purpose of this review is to summarize the current literature pertaining to the effects of TRE on body weight and cardiovascular disease risk factors.
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.
Current research: effect of time restricted eating on weight and cardiometabolic health. [2022]Intermittent fasting has grown in popularity as a weight loss strategy in recent years. In particular, time restricted eating (TRE) has been popularized in the diet industry with dozens of books touting its ability to promote weight loss and improve glucose regulation. TRE involves confining the eating window to a specified number of hours per day (usually 4-10 h), and fasting (with zero-calorie beverages) for the remaining hours of the day. While several studies of TRE have been performed in rodent models, human studies are only now emerging. The goal of this review is to summarize the effects of TRE on body weight and cardiometabolic disease risk factors in human subjects. Accumulating evidence shows that TRE may spontaneously decrease energy intake by 20-30% under ad libitum conditions, producing small but statistically significant weight loss of 1-4%. In addition, TRE may significantly decrease systolic and diastolic blood pressure independent of weight loss. Further, improvements in fasting insulin and insulin resistance have also been reported. Taken together, these preliminary data suggest that TRE produces mild weight loss, and also may improve some aspects of cardiometabolic health by lowering blood pressure and insulin resistance.
Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]Eating out of phase with the biological clock induces circadian misalignment in peripheral organs and impairs glucose tolerance in preclinical models. Time-restricted eating (TRE) is a dietary approach that consolidates energy intake to 6 to 10 hours during the biologically active phase of the day, without necessarily altering diet quality and quantity. TRE induces pleiotropic metabolic benefits in mice, flies, and humans. Most studies have initiated TRE early in the biological morning. This perspective discusses the potential challenges in translating early TRE to the community and considers the potential metabolic consequences of delaying TRE.
The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. [2022]The aim of this study is to assess the acceptability of following three different fasting protocols [Early Time-restricted Feeding (eTRF; eating majority of kcals before 5pm), Time-restricted Feeding (TRF; restricting feeding window to 8 h/d), or Alternate Day Fasting (ADF; complete fasting every other day)].
Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]Time-restricted eating (TRE), which restricts food intake to a limited duration of the day, is a key regimen of intermittent fasting.
Complex physiology and clinical implications of time-restricted eating. [2023]Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and physiological functions has been extensively studied in rodent models, which have shown considerable therapeutic effects of TRE and important interactions among time of eating, circadian biology, and metabolic homeostasis. In contrast, it is difficult to make firm conclusions regarding the effect of TRE in people because of the heterogeneity in results, TRE regimens, and study populations. In this review, we 1) provide a background of the history of meal consumption in people and the normal physiology of eating and fasting; 2) discuss the interaction between circadian molecular metabolism and TRE; 3) integrate the results of preclinical and clinical studies that evaluated the effects of TRE on body weight and physiological functions; 4) summarize other time-related dietary interventions that have been studied in people; and 4) identify current gaps in knowledge and provide a framework for future research directions.
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.
Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. [2023]Time-restricted feeding (TRF) is a kind of intermittent fasting defined as eating and drinking only during a certain number of hours in a day. It has been suggested that intermittent fasting may improve cardiovascular risk factors. This study evaluated the association of TRF and arterial stiffness, using pulse wave velocity (PWV), pulse wave analysis, and arterial age in metabolic syndrome participants.