Intermittent Fasting Interventions on Brain Health in Women

NCT05628727 | Terminated

• 1 other identifier: 14969
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Stress

Outcome Measures

Primary Outcomes (1)

• Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale

  Investigators will administer the standardized DASS-21 Questionnaire at Week 0 and Week 8. The stress sub-scale will be used to measure any potential effects of fasting interventions on psychological stress over time. The scoring of answers is based on a 0 to 3 scale. 3 reflects the negative extreme on the Likert Scale. Scores range from 0-42, higher scores are indicative of higher psychological stress levels.

  8 weeks

Secondary Outcomes (21)

• Colour and Word Stroop Test (SCWT)

  8 weeks

• Mnemonic Similarity Task (MST)

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• Eating Disorder Examination Questionnaire (EDE-Q 6.0)

  8 weeks

• Profile of Mood States (POMS)

  8 weeks

Study Arms (3)

5:2 Fasting Group

EXPERIMENTAL

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

Other: 5:2 Fasting

Time-Restricted Feeding Group

EXPERIMENTAL

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

Other: Time Restricted Feeding

Control Group

NO INTERVENTION

This group will not fast.

Interventions

Time Restricted Feeding OTHER

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

Also known as: TRF

Time-Restricted Feeding Group

5:2 Fasting OTHER

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

Also known as: 5:2 Method

5:2 Fasting Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English speaker
• Assignment of female sex at birth
• BMI between 18.5-24.9 kg/m\^2
• Current engagement in less than 150 minutes of physical activity per week
• Normal menstrual cycle length (21-40 days) for at least 3 months
• Non-smoker
• Consumption of no more than one alcoholic beverage per day
• Mild to higher levels of stress as indicated by a score of 15 or higher on the stress sub-set of the DASS-21 questionnaire

You may not qualify if:

• Pregnant or breastfeeding
• Diagnosed chronic disease (cardiovascular, metabolic, respiratory, reproductive, renal, neuromuscular, or any other disease or condition as assessed by the Canadian Society for Exercise Physiology Get Active Questionnaire)
• Diagnosed eating disorder
• Participation in a weight-loss program in the last 3 months
• Loss of 5% of body weight or more in the last 3 months

Sponsors & Collaborators

• McMaster University: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jennifer J Heisz, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 29, 2022
• Study Start: February 9, 2023
• Primary Completion: September 6, 2025
• Study Completion: September 6, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CA (1)