Time Restricted Feeding for Obesity

(TRIMM Trial)

Overseen By Jamie Baum, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Heart medications, Diabetes medications

Disqualifiers: Food allergies, Pregnant, Dietary restrictions, Obesity-related conditions, others

Compensation: Varies

Number of Visits: 4

Duration: 17 weeks

90 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 6 7 9}

Eligibility 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.

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.

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

Treatment Details

Interventions

• Control group - time restricted feeding only
• Ketogenic aid
• Whey protein supplement

Trial Overview 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.

Participant Groups

Group I: TRF-S Experimental Treatment 1 Intervention

Follows time restricted feeding protocol, consumes ketogenic supplement

Group II: TRF-P Experimental Treatment 1 Intervention

Follows time restricted feeding protocol, consumes protein supplement

Group III: TRF-C Placebo Group 1 Intervention

Follows time restricted feeding protocol.

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Findings from Research

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

Time-restricted feeding (TRF) led to greater weight loss compared to unrestricted meal timing, with an average loss of 1.07 kg across 11 studies involving 485 participants.

TRF also significantly reduced fasting glucose levels by an average of 1.71 mg/dL, indicating potential benefits for managing blood sugar levels, although more long-term studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Pellegrini, M., Cioffi, I., Evangelista, A., et al.[2021]

In a pilot study involving 40 abdominally obese participants, time-restricted feeding (TRF) led to a significant reduction in waist circumference by an average of 5.3 cm and improved blood sugar levels, as indicated by a decrease in HbA1c by 1.4 mmol/mol after three months.

TRF was well-adopted by participants, who achieved their fasting goals on 85.5% of recorded days, suggesting that this lifestyle modification could be an effective and easy-to-implement strategy for reducing abdominal obesity and lowering the risk of related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Time-Restricted Feeding and Impact on Abdominal Obesity in Primary Care Patients: Results of a Pilot Study in a Pre-Post Design. Kesztyüs, D., Cermak, P., Gulich, M., et al.[2022]

Time-restricted feeding (TRF) can effectively improve metabolic health in a mouse model of childhood obesity, particularly by normalizing liver fat content, which is a significant concern in obesity-related health issues.

Among two different TRF approaches tested, one (TRF2) led to reduced caloric intake and body weight, suggesting that the timing of food access can play a crucial role in managing obesity in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Feeding during Puberty Ameliorates Adiposity and Prevents Hepatic Steatosis in a Mouse Model of Childhood Obesity. Ribas-Aulinas, F., Parra-Vargas, M., Ramon-Krauel, M., et al.[2021]

Time-restricted feeding (TRF) has been shown to reduce body weight and improve various metabolic disease risk factors, such as lowering cholesterol and glucose levels, based on both animal and human studies.

Human studies indicate that while TRF consistently lowers triglycerides and improves cholesterol profiles, the effects on body weight are not always consistent, suggesting further research is needed to fully understand its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. Rothschild, J., Hoddy, KK., Jambazian, P., et al.[2018]

In a 12-month study involving 58 low-income women with obesity, time-restricted feeding (TRF) did not lead to significant weight loss compared to a standard hypoenergetic diet, indicating that TRF may not be effective for weight reduction in this population.

However, TRF was associated with a reduction in body fat percentage and waist circumference, suggesting it may have some benefits for body composition, even if these changes are not clinically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. de Oliveira Maranhão Pureza, IR., da Silva Junior, AE., Silva Praxedes, DR., et al.[2021]

Time-restricted feeding (TRF) for 8 hours a day over 4 weeks significantly reduced food intake and improved glucose tolerance in obese mice, indicating its efficacy in combating obesity-related metabolic issues.

The mechanism behind TRF's effectiveness involves the inhibition of the p38 MAPK/SIRT1/PGC-1α signaling pathway, which helps lower hyperglycemia and hepatic gluconeogenic activity, suggesting a novel nonpharmacological approach to managing obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding attenuates gluconeogenic activity through inhibition of PGC-1α expression and activity. She, Y., Sun, J., Hou, P., et al.[2021]

Time-restricted feeding (TRF) significantly reduced body weight and body mass index (BMI) in female college students with hidden obesity over an 8-week period, but it also led to increased blood lipid levels and decreased lean tissue mass.

Combining TRF with exercise did not provide additional benefits compared to TRF or exercise alone, indicating that TRF may not be the most effective strategy for fat reduction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. Liu, H., Chen, S., Ji, H., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Feeding during Puberty Ameliorates Adiposity and Prevents Hepatic Steatosis in a Mouse Model of Childhood Obesity. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. [2018]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Time-restricted feeding attenuates gluconeogenic activity through inhibition of PGC-1α expression and activity. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. [2023]