What side effects are associated with this type of intervention?

Common treatments for weight loss, such as time-restricted eating (TRE), low-carbohydrate diets, and low-fat diets, can have several side effects. TRE and other forms of intermittent fasting may lead to hunger, irritability, and reduced concentration during fasting periods. Low-carbohydrate diets can cause headaches, dizziness, fatigue, and constipation due to reduced fiber intake. Low-fat diets might result in deficiencies in essential fatty acids and fat-soluble vitamins if not properly balanced. It is important to monitor these side effects and consult with a healthcare provider to ensure nutritional adequacy and overall health.

What prior FDA approvals exist?

The FDA has approved several drugs for weight loss, including orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. These medications work through various mechanisms such as appetite suppression, increased satiety, and reduced fat absorption. While these drugs are effective for weight loss, the concept of time-restricted eating, which involves altering the timing of food intake to improve metabolic health, is still under investigation. Time-restricted eating aims to synchronize food intake with the body's circadian rhythms, potentially offering benefits for weight management and metabolic health beyond what pharmacotherapy alone can achieve.

What other types of research exist?

Promising, novel alternatives to Time-Restricted Eating for weight loss patients in 2024 include: 1) High-protein or low-glycemic index diets to improve metabolic health. 2) Cognitive Behavioral Therapy (CBT) to modify eating behaviors. 3) Pharmacotherapy, such as lisdexamfetamine, for appetite control. 4) Combined nutritional, psychological, and pharmacological treatments for a holistic approach.

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Time-Restricted Eating + Calorie Restriction for Weight Loss and Bone Health (TREMBO Trial)

N/A

Waitlist Available

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to an average 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from participating may include feelings of hunger due to calorie restriction and changes in energy levels or mood related to new eating patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to an average 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to an average 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to an average 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone mineral density (BMD - hip)

Microbiota

Weight loss

Secondary study objectives

Areal BMD (lumbar spine, femoral neck, radius, total body)

Blood pressure (systolic and diastolic)

Cortical bone (volumetric BMD, thickness, and porosity) and total BMD

+4 more

Other study objectives

25-hydroxyvitamin D (25OHD)

6 minute walk test

Circumferences

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time restricted eating and calorie restrictionExperimental Treatment2 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 aloneActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Calorie Restriction

2015

N/A

~480

Time Restricted Eating (TRE)

2020

N/A

~120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Time-restricted eating (TRE) is a weight loss strategy that involves limiting food intake to specific hours of the day, which can improve metabolic health by aligning eating patterns with the body's circadian rhythms. This approach can enhance insulin sensitivity, reduce appetite, and promote fat loss. Additionally, TRE may positively influence the gut microbiota by fostering a more balanced microbial environment, which can further support metabolic health. For weight loss patients, these mechanisms are crucial as they not only aid in reducing body weight but also improve overall metabolic function and potentially bone health, making TRE a holistic approach to weight management.

Linking the Gut Microbiota to Bone Health in Anorexia Nervosa.