Time-Restricted Eating for Cancer-Related Fatigue

Overseen By Amber Kleckner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Insulin

Disqualifiers: Underweight, Surgery planned, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking insulin or have any contraindications to the nutrition intervention, you may not be eligible to participate.

What data supports the effectiveness of the treatment Time-Restricted Eating for Cancer-Related Fatigue?

Research suggests that time-restricted eating (TRE) can improve metabolic health and reduce body weight, which may indirectly help with cancer-related fatigue. Although direct evidence in humans is limited, studies in animals show beneficial effects on energy metabolism and overall health. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in humans and generally appears safe, with some studies showing benefits like weight loss and improved cardiometabolic health. However, results can vary, and more research is needed to fully understand its effects across different populations. ^{1 2 3 6 7}

How is time-restricted eating different from other treatments for cancer-related fatigue?

Time-restricted eating (TRE) is unique because it focuses on limiting food intake to specific hours of the day, aligning with the body's natural circadian rhythms, which may help improve energy metabolism and reduce fatigue. Unlike other treatments that might involve medication or supplements, TRE is a dietary approach that leverages the timing of meals to potentially alleviate cancer-related fatigue. ^{2 5 6 8 9}

Eligibility Criteria

This trial is for cancer survivors who are at least 18 years old, have completed their main treatments between 2 months and 2 years ago, can use a smartphone, speak English, and consent to study procedures. They must feel fatigued (score of 4+ on a scale of 0-10) but not be underweight or have conditions like type 1 diabetes that could complicate the diet intervention.

Inclusion Criteria

I am 18 years old or older.

Be willing and able to adhere to study procedures, including use of a smartphone app

Own a smartphone

Exclusion Criteria

I am currently taking insulin.

I do not have conditions like type 1 diabetes, risk for low blood sugar, specific medication needs, pregnancy, breastfeeding, or a recent eating disorder that would prevent me from following the study's diet plan.

Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week time-restricted eating intervention or receive general health education

12 weeks

Weekly educational tips (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Healthy lifestyle education
• Time-restricted eating

Trial Overview The study tests if restricting eating to a 10-hour window each day for 12 weeks reduces fatigue in cancer survivors compared to those receiving general health education. Participants will be randomly assigned to either time-restricted eating or control group in equal numbers.

Participant Groups

Group I: Time-restricted eating Experimental Treatment 2 Interventions

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Group II: Control Experimental Treatment 1 Intervention

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

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) is a promising dietary approach that not only aids in weight management but also positively influences energy metabolism, gut microbiota, and overall homeostasis.

Chronodisruption, which occurs when our internal circadian rhythms are out of sync with external cues, is linked to serious health issues like metabolic disorders and cancer, highlighting the importance of aligning eating patterns with our biological clocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating for chronodisruption-related chronic diseases. Cheng, WY., Desmet, L., Depoortere, I.[2023]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

A time-restricted eating (TRE) intervention was found to be feasible and safe for cancer survivors, with 92.3% of the 39 participants completing the study without severe adverse events.

Participants experienced a significant reduction in cancer-related fatigue after two weeks of TRE, with improvements in fatigue scores indicating a moderate effect size, suggesting that TRE may be a beneficial strategy for managing fatigue in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. Kleckner, AS., Altman, BJ., Reschke, JE., et al.[2022]

A 4-week study on trained male endurance runners showed that a 16/8 time-restricted feeding (TRF) pattern led to a significant decrease in fat mass without affecting fat-free mass or running performance.

While the TRF group experienced lower carbon dioxide production and blood lactate levels during exercise, their 10 km time trial performance remained unchanged compared to those on a normal diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. Tovar, AP., Richardson, CE., Keim, NL., 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 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]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

References

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

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

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

Time-restricted eating for chronodisruption-related chronic diseases. [2023]

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

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]

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

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. [2021]

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

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. [2022]

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

Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. [2021]

7. United States 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. [2022]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]