Time Restricted Feeding for Obesity
(TRIMM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arkansas, Fayetteville
Must not be taking: Heart medications, Diabetes medications
Disqualifiers: Food allergies, Pregnant, Dietary restrictions, Obesity-related conditions, others
Trial Summary
What is the purpose of this trial?Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on prescription medications related to heart disease or type 2 diabetes.
What data supports the effectiveness of the treatment Time Restricted Feeding for Obesity?
Research shows that time-restricted feeding (TRF) can lead to mild weight loss and improvements in cardiometabolic health, such as reduced insulin resistance and oxidative stress, in adults with obesity. Studies also indicate that TRF is safe and can reduce waist circumference and fasting glucose levels, making it a promising approach for managing obesity.
12345Is time-restricted feeding safe for humans?
Research suggests that time-restricted feeding (TRF) is generally safe for humans, including those with obesity. Studies show no significant changes in adverse events, body image perception, or disordered eating patterns, indicating that TRF can be a safe method for weight loss.
12678How is time-restricted feeding different from other obesity treatments?
Time-restricted feeding (TRF) is unique because it focuses on limiting the hours during which you eat each day, rather than counting calories or restricting specific foods. This approach can lead to weight loss and improve some aspects of heart and metabolic health without the need for calorie counting.
12679Eligibility Criteria
This trial is for adults aged 25-50 living in Northwest Arkansas with a BMI over 25, regardless of ethnicity. It's not suitable for those with food allergies, dietary restrictions like vegetarianism, pre-existing obesity-related health conditions, heavy alcohol users, smokers/vapers, anyone who has tried to lose weight recently or fears needles. Pregnant/breastfeeding individuals and current supplement users are also excluded.Inclusion Criteria
BMI > 25
All ethnicities
I am between 25 and 50 years old.
+2 more
Exclusion Criteria
I have health issues like heart disease, diabetes, or high blood pressure due to being overweight.
Fear of needles
I am taking medication for heart disease or type 2 diabetes.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow a time restricted feeding protocol with different supplementations over 120 days
17 weeks
4 visits (in-person) at baseline, 4, 8, and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is examining how time-restricted feeding impacts muscle mass and metabolism as part of obesity prevention/treatment. Participants will either receive whey protein supplements or ketogenic aids alongside their diet or be part of a control group that practices time-restricted feeding without supplements.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TRF-SExperimental Treatment1 Intervention
Follows time restricted feeding protocol, consumes ketogenic supplement
Group II: TRF-PExperimental Treatment1 Intervention
Follows time restricted feeding protocol, consumes protein supplement
Group III: TRF-CPlacebo Group1 Intervention
Follows time restricted feeding protocol.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ArkansasFayetteville, AR
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Who Is Running the Clinical Trial?
University of Arkansas, FayettevilleLead Sponsor
References
Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. [2022]Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.
Safety of 8-h time restricted feeding in adults with obesity. [2019]This study examines the safety of time restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) in obese adults. Twenty-three subjects participated in an 8-h TRF intervention for 12 weeks. Self-reported adverse events, body image perception, complete blood count, and disordered eating patterns did not change from baseline to week 12. These findings suggest that consuming food within an 8-h window can safely facilitate weight loss in subjects with obesity.
Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. [2021]Restriction in meal timing has emerged as a promising dietary approach for the management of obesity and dysmetabolic diseases. The present systematic review and meta-analysis summarized the most recent evidence on the effect of time-restricted feeding (TRF) on weight-loss and cardiometabolic variables in comparison with unrestricted-time regimens. Studies involving TRF regimen were systematically searched up to January 2019. Effect size was expressed as weighted mean difference (WMD) and 95% confidence intervals (CI). A total of 11 studies, 5 randomized controlled trials and 6 observational, were included. All selected studies had a control group without time restriction; hours of fasting ranged from 12-h until 20-h and study duration from 4 to 8-weeks. Most studies involved the Ramadan fasting. TRF determined a greater weight-loss than control regimens (11 studies, n = 485 subjects) (WMD: -1.07 kg, 95%CI: -1.74 to -0.40; p = 0.002; I2 = 56.2%), unrelated to study design. The subgroup analysis showed an inverse association between TRF and fat free mass in observational studies (WMD: -1.33 kg, 95%CI: -2.55 to -0.11; p = 0.03; I2 = 0%). An overall significant reduction in fasting glucose concentrations was observed with TRF regimens (7 studies, n = 363 subjects) (WMD: -1.71 mg/dL, 95%CI: -3.20 to -0.21; p = 0.03; I2 = 0%), above all in trials (WMD:-2.45 mg/dL, 95%CI: -4.72 to -0.17; p = 0.03; I2 = 0%). No between-group differences in the other variables were found. TRF regimens achieved a superior effect in promoting weight-loss and reducing fasting glucose compared to approaches with unrestricted time in meal consumption. However, long-term and well-designed trials are needed to draw definitive conclusions.
Adherence to Time-Restricted Feeding and Impact on Abdominal Obesity in Primary Care Patients: Results of a Pilot Study in a Pre-Post Design. [2022]The epidemic of lifestyle-dependent diseases and the failure of previous interventions to combat the main causes demand an alternative approach. Abdominal obesity is associated with most of these diseases and is a good target for therapeutic and preventive measures. Time-restricted feeding (TRF) offers a low-threshold, easy-to-implement lifestyle-modification concept with promising results from animal testing. Here, we describe a pilot study of TRF with abdominally obese participants (waist-to-height ratio, WHtR ≥0.5) in a general practitioner's office. Participants (n = 40, aged 49.1 ± 12.4, 31 females) were asked to restrict their daily eating time to 8-9 hours in order to prolong their overnight fasting period to 15-16 hours. Questionnaires, anthropometrics, and blood samples were used at baseline and at follow-up. After three months of TRF, participants had reached the fasting target, on average, on 85.5 ± 15.2% of all days recorded. Waist circumference (WC) was reduced by -5.3 ± 3.1cm (p < 0.001), and three participants reached a WHtR <0.5. HbA1c was diminished by -1.4 ± 3.5 mmol/mol (p = 0.003). TRF may be an easily understandable and readily adoptable lifestyle change with the potential to reduce abdominal obesity and lower the risk for cardiometabolic diseases. Further well-designed studies are necessary to investigate the applicability and usefulness of TRF for public health.
Time-Restricted Feeding during Puberty Ameliorates Adiposity and Prevents Hepatic Steatosis in a Mouse Model of Childhood Obesity. [2021]Time restricted feeding (TRF) refers to dietary interventions in which food access is limited during a specific timeframe of the day. TRFs have proven useful in improving metabolic health in adult subjects with obesity. Their beneficial effects are mediated, in part, through modulating the circadian rhythm. Nevertheless, the translation of these dietary interventions onto obese/overweight children and adolescents remains uncharacterized. The objective of this study is to explore the feasibility of temporal dietary interventions for improving metabolic health in the context of childhood obesity.
Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. [2018]Time-restricted feeding (TRF), a key component of intermittent fasting regimens, has gained considerable attention in recent years. TRF allows ad libitum energy intake within controlled time frames, generally a 3-12 hour range each day. The impact of various TRF regimens on indicators of metabolic disease risk has yet to be investigated. Accordingly, the objective of this review was to summarize the current literature on the effects of TRF on body weight and markers of metabolic disease risk (i.e., lipid, glucoregulatory, and inflammatory factors) in animals and humans. Results from animal studies show TRF to be associated with reductions in body weight, total cholesterol, and concentrations of triglycerides, glucose, insulin, interleukin 6, and tumor necrosis factor-α as well as with improvements in insulin sensitivity. Human data support the findings of animal studies and demonstrate decreased body weight (though not consistently), lower concentrations of triglycerides, glucose, and low-density lipoprotein cholesterol, and increased concentrations of high-density lipoprotein cholesterol. These preliminary findings show promise for the use of TRF in modulating a variety of metabolic disease risk factors.
Effects of time-restricted feeding on body weight, body composition and vital signs in low-income women with obesity: A 12-month randomized clinical trial. [2021]Time-restricted feeding (TRF) studies usually are of short-term, involving heterogeneous populations, without a control group with similar energy restriction. Besides, it seldom assess vital signs such as body temperature and heart rate, which may be influenced by the fasting state. In this investigation, we assessed the long-term effects of TRF on body weight, body composition and vital signs of low-income women with obesity undergoing diets with the same energy deficit.
Time-restricted feeding attenuates gluconeogenic activity through inhibition of PGC-1α expression and activity. [2021]Time-restricted feeding (TRF), a key component of intermittent fasting regimens, has gained considerable attention in recent years due to reversing obesity and insulin resistance. To the best of our knowledge, here, we reported for the first time the underlying mechanistic therapeutic efficacy of TRF against hepatic gluconeogenic activity in obese mice.
Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. [2023]Time-restricted feeding (TRF) is an emerging dietary pattern with many potential effects. This study focused on the effects of TRF and walking on the physical health of female college students with hidden obesity.