Intermittent Fasting for Stress Management in Women

Overseen By Jennifer J Heisz, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Pregnant, Chronic disease, Eating disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different fasting diets might help reduce stress in women. Researchers will compare two groups: one following the 5:2 fasting method, which involves fasting for two days a week, and another practicing time-restricted feeding by eating only in the morning for 8 hours. The aim is to determine if these eating patterns can improve mental health and stress levels. Women who feel stressed, exercise less than 150 minutes a week, and have a regular menstrual cycle may be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how fasting diets can impact stress and mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that both the 5:2 fasting method and time-restricted eating are generally safe and well-tolerated by most people. Studies have found that the 5:2 diet can aid weight loss and improve heart health without major safety concerns. It is considered safe and feasible for individuals who are overweight or obese.

For time-restricted eating, research indicates it can enhance health by reducing calorie intake and boosting metabolism. Studies also suggest it might help with stress and anxiety, although more detailed research is needed.

Overall, these fasting methods are linked to positive health outcomes, and no major negative effects have been widely reported. However, individuals should consider their personal health and consult a healthcare professional before trying new diets. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about intermittent fasting techniques like the 5:2 fasting and time-restricted feeding for stress management because they offer a natural, non-pharmacological approach to improving mental health. Unlike traditional treatments for stress, which often involve medications or therapy, these methods focus on dietary patterns that may help regulate stress hormones and improve mood. The 5:2 method involves fasting on two non-consecutive days, potentially providing a unique rhythm to stress reduction, while time-restricted feeding limits eating to an 8-hour window, which could help stabilize energy levels and reduce stress-related eating. These approaches are seen as potentially more sustainable and accessible compared to ongoing medication regimens, making them appealing options for long-term stress management.

What evidence suggests that this trial's fasting diets could be effective for stress management in women?

This trial will compare the effects of two intermittent fasting methods on stress management in women. Research has shown that intermittent fasting can aid weight loss and improve mental health. Participants in the 5:2 Fasting Group will eat normally for five days and fast on two non-consecutive days each week. This method has been found to support weight loss and boost heart health. Meanwhile, participants in the Time-Restricted Feeding Group will limit eating to an 8-hour window each day, which can lead to modest weight loss and improved metabolism. Both methods can help reduce body weight and fat, potentially lowering stress levels. Although data specifically on stress in women is limited, these approaches show promise for enhancing overall mental well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer J Heisz, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adult women with a healthy body weight, who are not very physically active, have regular menstrual cycles, don't smoke or drink much alcohol, and feel quite stressed. Women can't join if they have mental health issues like anxiety or depression, recent significant weight loss or participation in a weight-loss program, pregnancy or breastfeeding status, medication affecting metabolism, or chronic diseases.

Inclusion Criteria

Normal menstrual cycle length (21-40 days) for at least 3 months

BMI between 18.5-24.9 kg/m^2

Non-smoker

Exclusion Criteria

I have a chronic disease like heart, lung, kidney issues, or others.

I have not joined a weight-loss program in the last 3 months.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants follow one of the fasting interventions or remain in the control group for 8 weeks. Mental health surveys, brain tests, and blood draws are conducted to assess changes.

8 weeks

2 visits (in-person), weekly online surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on motivation to continue the diet.

4 weeks

Online surveys

What Are the Treatments Tested in This Trial?

Interventions

• 5:2 Fasting
• Time Restricted Feeding

Trial Overview The study tests how two fasting diets affect stress levels and brain health in women over 8 weeks. One group will fast on two non-consecutive days each week (5:2 Fasting), another will eat only during an 8-hour window each day (Time Restricted Feeding), and there's also a control group for comparison.

How Is the Trial Designed?

Group I: Time-Restricted Feeding Group Experimental Treatment 1 Intervention

This group will use the 16:8 method every day, eating only during an 8-hour period that will commence at wake-up time.

Group II: 5:2 Fasting Group Experimental Treatment 1 Intervention

This group will use the 5:2 method and fast for two non-consecutive days of the week.

Group III: Control Group Active Control 1 Intervention

This group will not fast.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Published Research Related to This Trial

Intermittent fasting (IF) led to greater weight and body fat loss compared to calorie restriction (CR) in a study of 46 healthy women with overweight or obesity, suggesting that IF may be a more effective short-term weight loss strategy.

Despite the differences in weight loss, both IF and CR did not significantly affect perceived eating behaviors, mood, sleep quality, or cognitive performance, indicating that IF is a safe alternative to CR without negative impacts on psychological or cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight weeks of intermittent fasting versus calorie restriction does not alter eating behaviors, mood, sleep quality, quality of life and cognitive performance in women with overweight. Teong, XT., Hutchison, AT., Liu, B., et al.[2021]

Intermittent fasting (IF) has been shown to result in weight loss ranging from 0.8% to 13.0% of baseline weight across 27 trials, with no serious adverse events reported, indicating it is a safe option for treating obesity.

When compared to traditional calorie-restricted diets, IF produced equivalent weight loss results, and it also improved glycemic control in patients with type 2 diabetes, suggesting its potential effectiveness in managing obesity and related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. Welton, S., Minty, R., O'Driscoll, T., et al.[2021]

Intermittent fasting, particularly alternate-day fasting, has been shown to effectively reduce body weight by approximately 3%-7% and body fat by about 3-5.5 kg over periods of 3 to 12 weeks in various populations, including normal-weight, overweight, and obese individuals.

Whole-day fasting lasting 12 to 24 weeks also leads to significant reductions in body weight (≈3%-9%) and improvements in blood lipids, with total cholesterol decreasing by 5%-20% and triglycerides by 17%-50%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittent fasting on body composition and clinical health markers in humans. Tinsley, GM., La Bounty, PM.[2018]

Intermittent fasting (IF) participants, consisting of 44 women and 20 men, reported higher levels of eating disorder (ED) symptomatology compared to community norms, with 31.25% scoring at or above the clinical cutoff on the Eating Disorder Examination Questionnaire (EDE-Q).

The study indicates a concerning association between IF and ED behaviors, suggesting that individuals engaging in IF may be at risk for developing or exhibiting disordered eating patterns, highlighting the need for further research on this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting implementation and association with eating disorder symptomatology. Cuccolo, K., Kramer, R., Petros, T., et al.[2022]

Intermittent fasting, including methods like the 5:2 diet and time-restricted feeding, shows similar weight loss efficacy to standard daily calorie restriction, but many fasting models do not involve strict fasting cycles or complete fasting.

Longer fasting durations, particularly those extending beyond 16 hours, may enhance benefits like fat loss and improved insulin sensitivity, suggesting that the physiological effects of fasting could be more pronounced with sustained fasting periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. Templeman, I., Gonzalez, JT., Thompson, D., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9698935/

Effects of an Intermittent Fasting 5:2 Plus Program on Body ... A total of 85.7% of patients in the intermittent fasting 5:2 plus group lost more than 5% body weight, vs. 58.5% in the daily calorie restriction group (p = ...

2. withpower.com withpower.com/trial/intermittent-fasting-for-stress-management-in-women-16a6e

Intermittent Fasting for Stress Management in Women Intermittent fasting, particularly alternate-day fasting, has been shown to effectively reduce body weight by approximately 3%-7% and body fat by about 3-5.5 kg ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11876533/

Effect of the 5:2 Diet on Weight Loss and Cardiovascular ... Conclusion: The 5:2 diet is effective for weight reduction and amelioration of CVD risk factors in overweight/obesity and is safe and feasible. ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... Benefits of Intermittent fasting (IF) on health-related outcomes have been found in a range of randomised controlled trials (RCTs).

5. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01178-6

The impact of intermittent fasting on body composition and ... A systematic review and meta-analysis of randomized controlled trials of IF showed that IF effectively lowered TC and LDL, and reduced BW, BMI, ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2787246

Intermittent Fasting and Obesity-Related Health Outcomes Our findings suggest that IF is associated with successful weight loss and metabolic benefits among adults with obesity. MADF and the 5:2 diet ...

7. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...