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Psychological StressNCT05628727

Intermittent Fasting Interventions on Brain Health in Women

A study testing Time Restricted Feeding and 5:2 Fasting in people with Psychological Stress, run by McMaster University at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Psychological Stress
What is being tested?
Time Restricted Feeding and 5:2 Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
9 Feb 2023to 6 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Official title: Comparison of Intermittent Fasting Interventions on Brain Health in Women: A Randomized Controlled 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.

Being tested
Time Restricted Feeding, 5:2 Fasting
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time Restricted FeedingOther

    Also called TRF

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

  • 5:2 FastingOther

    Also called 5:2 Method

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

Study groups in NCT05628727
Study groupRoleWhat they receive
5:2 Fasting GroupExperimentalThis group will use the 5:2 method and fast for two non-consecutive days of the week.
Receives: Other: 5:2 Fasting
Time-Restricted Feeding GroupExperimentalThis group will use the 16:8 method every day, eating only during an 8-hour period that will commence at wake-up time.
Receives: Other: Time Restricted Feeding
Control GroupNo interventionThis group will not fast.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks

Secondary outcomes (21)

  1. Colour and Word Stroop Test (SCWT)

    Investigators will administer the standardized SCWT at Week 0 and Week 8 to assess the potential effects of fasting interventions on selective attention and response inhibition in participants over time.

    This task requires participants to name the displayed colour of the presented words while they disregard the meaning of the words.

    Several outcome measures will be produced:

    1. Reaction time (RT) in milliseconds (ms)
    2. The Stroop Effect - the difference in RT between incongruent and congruent trials, which can be broken down into 2 components:
    3. Stroop interference effect - the RT difference between incongruent and neutral trials
    4. Stroop facilitation effect - the RT difference between the neutral and congruent trials

    Measured: 8 weeks

  2. Mnemonic Similarity Task (MST)

    Investigators will administer the standardized MST to assess the potential effects of fasting interventions on high interference memory over time.

    Several outcome measures will be produced:

    1. Reaction time
    2. High-interference memory (assessed as the ability to correctly identify lure items as ''Similar'')
    3. General recognition memory performance (assessed as the ability to correctly identify repetitions items as ''Old'')

    Measured: 8 weeks

  3. Pittsburgh Sleep Quality Index (PSQI)

    Investigators will administer the standardized PSQI at Week 0 and Week 8 to measure the self-reported quality and patterns of sleep in adults.

    Several outcomes will be measured:

    1. Subjective sleep quality
    2. Sleep latency
    3. Sleep duration
    4. Habitual sleep efficiency
    5. Sleep disturbances
    6. Use of sleeping medication
    7. Daytime dysfunction over the last month

    The scoring of answers is based on a 0 to 3 scale. 3 reflects the negative extreme on the Likert Scale. Scores range from 0-21, where higher scores are indicative of poorer sleep quality and a global score of >5 is indicative of poor sleep quality.

    Measured: 8 weeks

  4. Eating Disorder Examination Questionnaire (EDE-Q 6.0)

    Investigators will administer the standardized EDEQ-6.0 during screening and Week 8 to measure self-reported disordered eating patterns in adults and the potential effects of fasting interventions on this outcome measure over time.

    2 main outcomes will be measured:

    1. Frequency data on key behavioural features of eating disorders in terms of the number of episodes of the behaviour.
    2. Sub-scale scores reflect the severity of characteristics of eating disorders. The sub-scales are Restraint, Eating Concern, Shape Concern and Weight Concern.

    Generally, sub scales are measures on a 7-point Likert scale. Higher scores on the global scale and sub-scales denote more problematic eating behaviours and attitudes.

    Measured: 8 weeks

  5. Profile of Mood States (POMS)

    Investigators will administer the standardized POMS at Week 0 and Week 8 to measure the potential effects of fasting interventions on self-reported quality and patterns of sleep in adults over time.

    Several outcomes will be measured:

    1. Total Mood Disturbance [TMD] (-32 to 200) Subscales:
    2. Anger (0-48)
    3. Confusion (0-28)
    4. Depression (0-60)
    5. Fatigue (0-28)
    6. Tension (0-36)
    7. Vigour (0-32)

    The scoring of answers is based on a 5-point Likert scale (not at all - extremely). Higher TMD scores are indicative of a poorer mood state.

    Measured: 8 weeks

  6. State Anxiety Inventory (STAI) Short Form

    Investigators will administer the standardized STAI at Week 0 and Week 8 to measure the potential effects of fasting interventions on self-reported state and trait anxiety levels over time.

    All items are rated on a 4-point Likert scale (e.g., from "Almost Never" to "Almost Always"), with higher scores indicating greater anxiety levels.

    Measured: 8 weeks

  7. Five Facet Mindfulness Questionnaire (FFMQ)

    Investigators will administer the standardized FFMQ at Week 0 and Week 8 to measure the potential effects of fasting interventions on the self-reported trait-like tendency to be mindful in daily life. It is comprised of the following five related facets: observing, describing, acting with awareness, non-judging, and non-reactivity.

    The 39 items of the FFMQ are rated on a 5-point Likert scale: ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores can also be combined to produce an overall mindfulness score.

    A higher score indicates a greater trait-like tendency to be mindful in daily life.

    Measured: 8 weeks

  8. Blood Pressure

    Investigators will use an automated sphygmomanometer to measure blood pressure during each of the 2 in-lab sessions.

    Several measures will be collected:

    1. MAP (mmHg)
    2. Systolic pressure (mmHg)
    3. Diastolic pressure (mmHg)

    Measured: 8 weeks

  9. Height (cm)

    Investigators will use a vertical scale via measuring tape to measure height (cm) during each of the 2 in-lab sessions.

    Measured: 8 weeks

  10. Weight (kg)

    Investigators will use an automated scale to measure weight (kg) during each of the 2 in-lab sessions.

    Measured: 8 weeks

  11. Waist Circumference (cm)

    Investigators will use a flexible measuring tape to measure waist circumference (cm) during each of the 2 in-lab sessions.

    Measured: 8 weeks

  12. Inflammatory Biomarker Interleukin-6 [IL6] (pg/mL)

    A trained researcher who has completed phlebotomy course will take ~8 ml of blood will be drawn from an antecubital (forearm) vein at rest. The blood will be used to measure biomarkers of inflammation (e.g., proinflammatory cytokines IL6, TNF-a, CRP) during 2 in-lab sessions at week 0 and week 8.

    Measures will be recorded in pg/mL. A higher value will indicate higher levels of inflammation.

    Measured: 8 weeks

  13. Inflammatory Biomarker Tumour Necrosis Factor Alpha [TNF-a] (pg/mL)

    A trained researcher who has completed a phlebotomy course will take ~8 ml of blood will be drawn from an antecubital (forearm) vein at rest. The blood will be used to measure biomarkers of inflammation (e.g., proinflammatory cytokines IL6, TNF-a, CRP) during 2 in-lab sessions at week 0 and week 8.

    Measures will be recorded in pg/mL. A higher value will indicate higher levels of inflammation.

    Measured: 8 weeks

  14. Inflammatory Biomarker C-Reactive Protein [CRP] (mg/L)

    A trained researcher who has completed a phlebotomy course will take ~8 ml of blood will be drawn from an antecubital (forearm) vein at rest. The blood will be used to measure biomarkers of inflammation (e.g., proinflammatory cytokines IL6, TNF-a, CRP) during 2 in-lab sessions at week 0 and week 8.

    Measures will be recorded in mg/L. A higher value will indicate higher levels of inflammation.

    Measured: 8 weeks

  15. Blood Ketone Levels (mmol/L)

    Participants will perform finger pricks using a lancing device and measure blood ketone levels using a ketometer. Values will be recorded in mmol/L, with higher values indicating higher levels of circulating blood ketones.

    Measured: 8 weeks

  16. Blood Glucose Levels (mmol/L)

    Participants will perform finger pricks using a lancing device and measure blood ketone levels using a glucometer. Values will be recorded in mmol/L, with higher values indicating higher levels of circulating blood glucose.

    Measured: 8 weeks

  17. Body Composition (% Body Fat)

    Body composition (% body fat and lean body mass) will be measured in participants by investigators using a DEXA (DXA) scanner during the 2 in-lab sessions at Week 0 and Week 8. Higher percentages indicate a higher percent body fat and lower relative lean body mass.

    Measured: 8 weeks

  18. Body Composition (Lean Body Mass - kg)

    Body composition (% body fat and lean body mass) will be measured in participants by investigators using a DEXA (DXA) scanner during the 2 in-lab sessions at Week 0 and Week 8. Measures will be recorded in kg. A higher lean body mass indicates a lower relative body fat percentage.

    Measured: 8 weeks

  19. Body Mass Index (BMI)

    Body Mass Index will use participant height and weight as input values to produce a measure in kg/m^2 at Week 0 and Week 8. A higher BMI score indicates a relatively higher body fat percentage.

    Measured: 8 weeks

  20. Diet Satisfaction & Adherence Questionnaire

    Investigators will administer standardized questions taken from the Diet Satisfaction Questionnaire in addition to adherence questions to measure weekly dietary satisfaction and adherence to the fasting interventions during the intervention.

    Scoring is qualitative.

    Measured: 8 weeks

  21. Pregnancy Status

    Investigators will collect a urine sample and test it to determine the pregnancy status of the participant as per the exclusion criteria.

    A test strip will be placed in the urine. A positive pregnancy status will be indicated by the appearance of 2 lines in their respective locations on the strip. A negative pregnancy status will be indicated by the presence of only one line in its respective location on the strip.

    Measured: One time measure at Week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start9 Feb 2023
  3. Primary completion6 Sep 2025
  4. Study completion6 Sep 2025

Why it stopped: Difficulty with recruiting

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628727
Sponsor's protocol ID
14969
Status last verified
Sep 2025
First submitted
8 Nov 2022
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Time Restricted Feeding and 5:2 Fasting in people with Psychological Stress, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Difficulty with recruiting). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05628727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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