Time-Restricted Eating + Calorie Restriction for Weight Loss and Bone Health

(TREMBO Trial)

Not currently recruiting at 1 trial location

Overseen By Brandon McGuire

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Bisphosphonates, Hormone replacement

Disqualifiers: Cancer, Diabetes, Bone diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two eating strategies affect weight loss, gut health, and bone health in postmenopausal women who are overweight or obese. It compares a calorie-restricted diet to a calorie-restricted diet combined with time-restricted eating (eating within a 9-hour window). Women who have not had a menstrual period for over two years and can attend about 10 on-site visits in New Brunswick, NJ, may be suitable participants. The researchers aim to determine if meal timing, alongside calorie reduction, leads to better health outcomes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary strategies for improved health.

Will I have to stop taking my current medications?

The trial requires that you do not regularly use medications that affect bone metabolism, like bisphosphonates or hormone replacement. If you are on these medications, you may need to stop taking them to participate.

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

Research has shown that time-restricted eating (TRE) combined with calorie reduction is generally safe for most people. Studies have found that individuals following these eating patterns usually tolerate them well. Serious side effects are rare, though some may experience hunger or irritability, especially initially.

In past research, time-restricted eating involved consuming food only during specific hours each day. This method is popular for weight loss and is generally safe. When combined with calorie reduction, it is also well-tolerated. Various studies have examined this combination and found it to be non-harmful.

Overall, for those considering participation in a study on TRE and calorie restriction, research suggests these methods are usually safe for most people. However, as with any dietary change, it is important to monitor personal well-being and consult healthcare professionals if any concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of time-restricted eating (TRE) and calorie restriction because it offers a unique approach to weight loss and bone health. Unlike traditional methods that focus solely on reducing caloric intake, TRE adds a timing element by limiting food consumption to a 9-hour window each day. This approach could potentially enhance metabolic outcomes and improve adherence by structuring eating patterns without additional caloric reduction. By combining both strategies, this method might provide more sustainable and effective results compared to standard calorie restriction alone.

What evidence suggests that this trial's treatments could be effective for weight loss and bone health?

Research has shown that combining time-restricted eating (TRE) with calorie restriction (CR) can lead to better weight loss and improved health compared to just cutting calories. In this trial, some participants will follow both TRE and CR, often resulting in more weight loss. This combination might also enhance health by improving insulin use and lowering risks for heart problems, such as high blood pressure. However, some studies suggest that TRE alone may not always lead to more weight loss than simply reducing calories. Overall, evidence supports that TRE combined with CR could be more effective for losing weight and improving health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who are overweight or obese, with a BMI of 25-39 kg/m2 and eat over a span of at least 14 hours daily. They must be able to visit the site in New Brunswick, NJ without travel reimbursement. Women taking certain bone medications, those with recent significant weight loss or extreme diets, smokers, and those with various health conditions including uncontrolled hypertension cannot participate.

Inclusion Criteria

I am a woman who has not had a menstrual period for over 2 years.

Body mass index (25-45 kg/m2)

Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)

Exclusion Criteria

Shift work

Alcohol or illicit drug abuse

Participation in another clinical research trial which may interfere with the results of this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a calorie-restricted diet with or without time-restricted eating for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calorie Restriction
• Time Restricted Eating (TRE)

Trial Overview The TREMBO study is testing if eating within a set time frame each day plus cutting calories helps older women lose weight better than just cutting calories alone. It also looks at how this might affect the good bacteria in their guts and their bone health.

How Is the Trial Designed?

Group I: Time restricted eating and calorie restriction Experimental Treatment 2 Interventions

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).

Group II: Calorie restriction alone Active Control 1 Intervention

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. They will be advised to continue to consume foods throughout the day and into the evening.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

In a 12-week study with 20 participants, time-restricted eating (TRE) led to significant changes in meal timing, including delaying the first meal by nearly 3 hours and advancing the last meal by over 1 hour, which may contribute to weight loss and improved health outcomes.

The TRE group also significantly reduced late-night eating by 14%, with 63% of participants completely eliminating late-night eating, and this was associated with longer sleep duration, suggesting that TRE may improve overall eating patterns and sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a self-selected time restricted eating intervention on eating patterns, sleep, and late-night eating in individuals with obesity. Simon, SL., Blankenship, J., Manoogian, ENC., et al.[2023]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

In a study of 36 women with overweight or obesity, those following an 8-week time-restricted eating (TRE) plan experienced greater weight loss and reductions in body fat compared to a non-TRE group, despite both groups following a caloric restriction diet.

The weight loss observed in the TRE group was not linked to changes in resting metabolic rate or improvements in mood or eating disorder symptoms, suggesting that TRE can be effective for weight loss without affecting these behavioral factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic and behavioral effects of time-restricted eating in women with overweight or obesity: Preliminary findings from a randomized study. Fagundes, GBP., Tibães, JRB., Silva, ML., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10708501/

Effectiveness of Time-Restricted Eating with Caloric ... Recent studies suggest that combining TRE with caloric restriction (CR) may have more favorable effects on both physical and biochemical aspects ...

2. nature.com nature.com/articles/s41430-023-01311-w

Time-restricted eating with calorie restriction on weight loss ... Our systematic review and meta-analysis demonstrated that calorie-intake restriction with time restriction could significantly decrease body ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38068769/

Effectiveness of Time-Restricted Eating with Caloric ... Recent studies suggest that combining TRE with caloric restriction (CR) may have more favorable effects on both physical and biochemical aspects ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... In this 12-month trial, we found that the 8-hour time-restricted–eating regimen did not produce greater weight loss than the regimen of daily ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1658361225000186

Evaluation of the effectiveness of intermittent fasting versus ... Furthermore, IF significantly improves glycemic control and insulin sensitivity; decreases cardiovascular risk by decreasing resting heart rate, BP, fat mass, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35443107/

Calorie Restriction with or without Time-Restricted Eating ... Conclusions: Among patients with obesity, a regimen of time-restricted eating was not more beneficial with regard to reduction in body weight, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8190218/

Intermittent fasting: from calories to time restriction - PMC TRF is a form of dietary restriction accomplished by limiting eating to less than 10 h per day, without an overall reduction in daily caloric intake [27]. Many ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity Time-restricted eating (TRE) has become a popular strategy to treat obesity. TRE involves confining the eating window to 4–10 h per day and fasting for the ...