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

(TREMBO Trial)

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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a diet where older women who are overweight or obese eat only during certain times and reduce their calorie intake. The goal is to see if this helps them lose weight, improve heart health, and strengthen bones by changing gut bacteria.

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.

What data supports the effectiveness of the treatment Time-Restricted Eating + Calorie Restriction for weight loss and bone health?

Research shows that time-restricted eating (TRE), especially when combined with calorie restriction, can lead to significant weight loss and improvements in insulin resistance in overweight and obese adults. TRE involves eating within a specific time window each day, which has been found to help with weight control and may have positive effects on glucose metabolism. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) is generally considered safe for humans, as it involves limiting the daily eating window without severe calorie restriction. Studies have explored its effects on weight, cardiovascular health, and bone metabolism, indicating it can be a safe dietary approach for improving health markers. ^{2 4 5 6 7}

How is the treatment of time-restricted eating and calorie restriction unique for weight loss and bone health?

This treatment is unique because it combines time-restricted eating (TRE), where you eat only during a specific time window each day, with calorie restriction, which reduces overall calorie intake. Unlike other weight loss methods, TRE aligns eating patterns with the body's natural biological clock, potentially offering additional metabolic benefits. ^{2 4 8 9 10}

Eligibility Criteria

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

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

Alcohol or illicit drug abuse

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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), 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]

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]

References

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

Is time-restricted eating (8/16) beneficial for body weight and metabolism of obese and overweight adults? A systematic review and meta-analysis of randomized controlled trials. [2023]

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

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

3. United States 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. [2023]

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

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

The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Food Timing, Circadian Rhythm and Chrononutrition: A Systematic Review of Time-Restricted Eating's Effects on Human Health. [2021]

7. Switzerland 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. [2023]

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

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

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

Complex physiology and clinical implications of time-restricted eating. [2023]

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

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]