Time-Restricted Eating for Obesity

(SHIFT Trial)

Overseen By UCSD Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Salk Institute for Biological Studies

Must be taking: Cardiovascular medications

Must not be taking: Insulin, SGLT2 inhibitors, GLP1 agonists

Disqualifiers: Type 1 diabetes, Pregnancy, Cardiovascular events, others

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

Compensation: Varies

Number of Visits: 4

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications, especially if you are on cardiovascular medications like statins, metformin, or anti-hypertensive drugs. However, if you are using medications known to cause weight loss or have had recent changes in medications that could impact study outcomes, you may not be eligible to participate.

Is time-restricted eating safe for humans?

The studies on time-restricted eating (TRE) suggest it is generally safe for humans, as it focuses on eating within a specific time window each day, which can help improve metabolic health and support weight management. ^{1 2 3 4 5}

How does the treatment Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) differ from other treatments for obesity?

Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) is unique because it combines a specific eating schedule with a low-calorie, high-fat, low-carbohydrate snack to enhance the benefits of fasting, potentially improving weight loss and blood sugar control. Unlike other treatments, it focuses on the timing of food intake and the metabolic effects of fasting, rather than just calorie reduction. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Time-Restricted Eating for Obesity?

Research shows that time-restricted eating (TRE) can help with weight loss and improve blood sugar levels in people with obesity and type 2 diabetes. TRE involves eating within a specific time window each day, which may help improve metabolic health and support weight management. ^{2 3 5 6 7}

Who Is on the Research Team?

Emily Manoogian, Ph.D.

Principal Investigator

Salk Institute for Biological Studies

Are You a Good Fit for This Trial?

This trial is for nurses and nursing assistants who work night shifts, eat over a span of 14 hours or more daily, and are overweight. The study aims to see if changing when they eat can affect their health.

Inclusion Criteria

Have been doing night shift work for at least 3 months

I work night shifts as a nurse or nursing assistant for at least 3 days a week.

Own a smartphone (Apple iOS or Android OS)

Exclusion Criteria

Fasting LDL cholesterol greater than 250 mg/dL

Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest

Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Guided Intervention

Participants undergo a 6-month guided intervention with dietary monitoring and time-restricted eating

6 months

Monthly visits (in-person or virtual)

Self-Guided Intervention

Participants continue with a 6-month self-guided intervention following the initial guided phase

6 months

Quarterly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

Health assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Monitoring
• Time-Restricted Eating (TRE)
• Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)

Trial Overview The trial tests three strategies: just tracking what participants eat, limiting eating to a 10-hour window during the day, or doing that plus having a low-glycemic snack at night. Their health will be checked before starting and after 3, 6 (main check), and 12 months.

How Is the Trial Designed?

Group I: Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS) Experimental Treatment 1 Intervention

Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts.

Group II: Time-Restricted Eating (TRE) Experimental Treatment 1 Intervention

Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window

Group III: Dietary Monitoring Active Control 1 Intervention

Log all dietary intake and continue habitual eating patterns.

Who Is Running the Clinical Trial?

Salk Institute for Biological Studies

Lead Sponsor

Trials

23

Recruited

2,200+

University of San Diego

Collaborator

Trials

6

Recruited

11,100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

The RESET study is a randomized controlled trial involving 100 participants at high risk for type 2 diabetes, investigating the effects of time-restricted eating (TRE) on body weight and metabolic health over a 3-month intervention period.

The primary outcome is the change in body weight after 3 months, with secondary outcomes including various metabolic and behavioral measures, aiming to determine the effectiveness and feasibility of TRE for improving health in individuals with overweight or obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. Quist, JS., Jensen, MM., Clemmensen, KKB., et al.[2022]

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]

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

A 4-week, 9-hour time-restricted eating (TRE) protocol significantly improved glycaemic control in 19 adults with type 2 diabetes, reducing mean 24-hour glucose concentrations and total area under the curve (AUC) without changing dietary intake or physical activity levels.

Participants experienced 10% more time in the target glucose range and 10% less time above the target range during the TRE period, indicating enhanced blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. Parr, EB., Steventon-Lorenzen, N., Johnston, R., et al.[2023]

Time-restricted eating (TRE) is a promising dietary strategy that can help improve metabolic health and restore circadian rhythms, potentially aiding in the prevention and treatment of obesity and its complications.

Current evidence from previous TRE trials suggests a need for more extensive clinical research, including large-scale controlled trials, to fully understand the efficacy and mechanisms of TRE in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. He, JH., Sun, CY., Liang, C.[2022]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

Citations

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

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. [2022]

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

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. [2023]

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

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

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

Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. [2022]