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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted feeding (also known as time-restricted eating or intermittent fasting) and protein timing can help manage or prevent obesity. Participants will follow a schedule that limits eating times, and some will also take protein or ketogenic (low-carb, high-fat) supplements. Researchers aim to assess how these approaches affect appetite and energy use, focusing on muscle mass. Ideal participants are adults living in Northwest Arkansas with a BMI over 25 who aren't on certain medications or diets and don't have major health issues related to obesity. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new strategies for managing obesity.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both whey protein and ketogenic supplements are generally safe for most adults. Whey protein is usually safe when used correctly, though some individuals might experience minor side effects like more frequent bowel movements. Various health organizations also consider it safe.

For ketogenic supplements, evidence suggests they are safe for many people, but they might not be suitable for everyone, especially those with kidney disease. Individuals with kidney issues need to follow specific diets and should exercise caution.

Overall, most people tolerate these supplements well. Prospective trial participants should consult a healthcare professional to determine if these treatments are appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the time restricted feeding (TRF) treatments for obesity because they offer a unique approach compared to traditional methods like calorie counting or medication. The TRF-C group follows a specific eating schedule without any supplements, which could simplify weight management by aligning eating patterns with natural circadian rhythms. The TRF-P group adds a protein supplement, potentially enhancing muscle maintenance and metabolism during weight loss. The TRF-S group incorporates a ketogenic supplement to promote fat burning and sustain energy levels. These varied approaches aim to provide more flexible and potentially effective ways to tackle obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that eating within a specific time window each day, known as time-restricted feeding (TRF), can aid in weight loss. In this trial, one group will follow the TRF protocol alone, while another group will combine TRF with a whey protein supplement. In one study, participants who combined TRF with a whey protein supplement lost 6.1% of their body fat, which is significant for reducing obesity risk.

For the ketogenic supplement, another group in this trial will follow the TRF protocol while consuming a ketogenic supplement. Studies indicate that ketogenic diets can effectively support weight loss and improve overall health. This diet is linked to better body composition and enhanced physical performance. Although it may not surpass other diets in weight loss, it offers unique health benefits. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 am taking medication for heart disease or type 2 diabetes.

Fear of needles

I have health issues like heart disease, diabetes, or high blood pressure due to being overweight.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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) 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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220164/

Effect of a ketogenic diet, time-restricted eating, or alternate ... We found that both KD and mADF may be effective dietary interventions for weight loss in the short term. Previously, Yancy et al. showed that a ...

2. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(24)00307-8/fulltext

Effects of time-restricted eating and low-carbohydrate diet ... Low carb and ketogenic diets increase quality of life, physical performance, body composition, and metabolic health of women with breast cancer.

3. academic.oup.com academic.oup.com/nutritionreviews/article/83/10/1957/8043247

Impact of Ketogenic Nutrition on Obesity and Metabolic Health Recently, the KD, due to its effectiveness in inducing weight loss, has also been proposed as a possible approach to treat obesity. Likewise, a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1933287419302673

Review of current evidence and clinical recommendations ... Based on the evidence reviewed, low-CHO and very-low-CHO diets are not superior to other dietary approaches for weight loss. These diets may have advantages ...

5. jofem.org jofem.org/index.php/jofem/article/view/944/284284712

Role of Ketogenic Diets and Intermittent Fasting in ... KD and IF may help with weight loss, diabetes, cardiovascular disease, polycystic ovarian syndrome, cancer, and chronic neurological illnesses.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9396320/

Current Evidence Concerning Effects of Ketogenic Diet and ... This article reviews specifically whether these trendy dietary patterns have an effect on NAFLD outcomes regarding intrahepatic fat content, fibrosis, and ...

7. nature.com nature.com/articles/s41392-021-00831-w

Ketogenic diet for human diseases: the underlying ... The ketogenic diet (KD) is a high-fat, adequate-protein, and very-low-carbohydrate diet regimen that mimics the metabolism of the fasting state to induce the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9705794/

Ketogenic diets and Ketone suplementation: A strategy for ... Ketogenic diets and orally administered exogenous ketone supplements are strategies to increase serum ketone bodies serving as an alternative energy fuel.

9. everydayhealth.com everydayhealth.com/ketogenic-diet/diet/keto-diet-dangers-you-need-know/

The 11 Biggest Keto Diet Dangers You Need to Know About And the ketogenic diet can be dangerous for people with kidney disease, as people with kidney disease need to follow an individualized diet prescribed by their ...