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

96 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 5:2 Fasting, Time Restricted Feeding for stress management in women?

Research shows that intermittent fasting, like the 5:2 method, can lead to weight and body fat loss without negatively affecting mood, sleep, or quality of life in women with overweight. Additionally, fasting for longer periods may improve fat mass and insulin sensitivity, which are linked to better overall health. ^{1 2 3 4 5}

Is intermittent fasting safe for women?

Intermittent fasting appears to be generally safe for women, as studies show it does not negatively impact mood, sleep quality, or cognitive performance in the short term. However, it may be associated with eating disorder symptoms in some individuals, so caution is advised. More research is needed to understand long-term safety. ^{1 2 3 5 6}

How does the 5:2 fasting treatment for stress management in women differ from other treatments?

The 5:2 fasting treatment is unique because it involves eating normally for five days and significantly reducing calorie intake for two non-consecutive days each week. This approach may offer benefits similar to calorie restriction without the need for daily dieting, potentially making it easier to adhere to while still promoting weight loss and metabolic health. ^{2 5 7 8 9}

What is the purpose of this trial?

Adults experience high psychological stress due to many factors such as school, workplace, or personal life. Adult women are known to experience higher stress levels than men. Current evidence shows that fasting improves mental health outcomes in men. The research is unclear on fasting interventions and their potential impact on stress levels in women. In this study, investigators will compare two fasting diets over 8 weeks. There will be a control group, one group that fasts for two days per week, and a final group that only eats for 8 hours in the morning. Mental health surveys, brain tests and a blood draw will be done during the study to see any mental or physical changes from the diets. Investigators will study the motivation of women to continue the diet during and beyond the study through online surveys.

Research Team

Jennifer J Heisz, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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 (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, 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]

References

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

Effects of intermittent fasting on body composition and clinical health markers in humans. [2018]

2. United States 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. [2021]

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

Intermittent fasting implementation and association with eating disorder symptomatology. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Role of therapeutic fasting in women's health: An overview. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Short Term Caloric Restriction and Biofeedback Enhance Psychological Wellbeing and Reduce Overweight in Healthy Women. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Effects of 2-day calorie restriction on cardiovascular autonomic response, mood, and cognitive and motor functions in obese young adult women. [2019]

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

Group differences in binge eating, impulsivity, and intuitive and mindful eating among intermittent fasters and non-fasters. [2023]