Back to resultsIntermittent Fasting Interventions on Brain Health in Women
Primary Purpose
Psychological Stress
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Time Restricted Feeding
5:2 Fasting
Sponsored by
About this trial
This is an interventional prevention trial for Psychological Stress
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: 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
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
5:2 Fasting Group
Time-Restricted Feeding Group
Control Group
Arm Description
This group will use the 5:2 method and fast for two non-consecutive days of the week.
This group will use the 16:8 method every day, eating only during an 8-hour period that will commence at wake-up time.
This group will not fast.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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:
Reaction time (RT) in milliseconds (ms)
The Stroop Effect - the difference in RT between incongruent and congruent trials, which can be broken down into 2 components:
Stroop interference effect - the RT difference between incongruent and neutral trials
Stroop facilitation effect - the RT difference between the neutral and congruent trials
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:
Reaction time
High-interference memory (assessed as the ability to correctly identify lure items as ''Similar'')
General recognition memory performance (assessed as the ability to correctly identify repetitions items as ''Old'')
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:
Subjective sleep quality
Sleep latency
Sleep duration
Habitual sleep efficiency
Sleep disturbances
Use of sleeping medication
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.
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:
Frequency data on key behavioural features of eating disorders in terms of the number of episodes of the behaviour.
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.
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:
Total Mood Disturbance [TMD] (-32 to 200)
Subscales:
Anger (0-48)
Confusion (0-28)
Depression (0-60)
Fatigue (0-28)
Tension (0-36)
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.
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.
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.
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:
MAP (mmHg)
Systolic pressure (mmHg)
Diastolic pressure (mmHg)
Height (cm)
Investigators will use a vertical scale via measuring tape to measure height (cm) during each of the 2 in-lab sessions.
Weight (kg)
Investigators will use an automated scale to measure weight (kg) during each of the 2 in-lab sessions.
Waist Circumference (cm)
Investigators will use a flexible measuring tape to measure waist circumference (cm) during each of the 2 in-lab sessions.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05628727
First Posted
November 8, 2022
Last Updated
July 18, 2023
Sponsor
McMaster University
Collaborators
Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05628727
Brief Title
Intermittent Fasting Interventions on Brain Health in Women
Official Title
Comparison of Intermittent Fasting Interventions on Brain Health in Women: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Natural Sciences and Engineering Research Council, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5:2 Fasting Group
Arm Type
Experimental
Arm Description
This group will use the 5:2 method and fast for two non-consecutive days of the week.
Arm Title
Time-Restricted Feeding Group
Arm Type
Experimental
Arm Description
This group will use the 16:8 method every day, eating only during an 8-hour period that will commence at wake-up time.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not fast.
Intervention Type
Other
Intervention Name(s)
Time Restricted Feeding
Other Intervention Name(s)
TRF
Intervention Description
This group will use the 16:8 method every day, eating only during an 8-hour period that will commence at wake-up time.
Intervention Type
Other
Intervention Name(s)
5:2 Fasting
Other Intervention Name(s)
5:2 Method
Intervention Description
This group will use the 5:2 method and fast for two non-consecutive days of the week.
Primary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Colour and Word Stroop Test (SCWT)
Description
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:
Reaction time (RT) in milliseconds (ms)
The Stroop Effect - the difference in RT between incongruent and congruent trials, which can be broken down into 2 components:
Stroop interference effect - the RT difference between incongruent and neutral trials
Stroop facilitation effect - the RT difference between the neutral and congruent trials
Time Frame
8 weeks
Title
Mnemonic Similarity Task (MST)
Description
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:
Reaction time
High-interference memory (assessed as the ability to correctly identify lure items as ''Similar'')
General recognition memory performance (assessed as the ability to correctly identify repetitions items as ''Old'')
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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:
Subjective sleep quality
Sleep latency
Sleep duration
Habitual sleep efficiency
Sleep disturbances
Use of sleeping medication
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.
Time Frame
8 weeks
Title
Eating Disorder Examination Questionnaire (EDE-Q 6.0)
Description
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:
Frequency data on key behavioural features of eating disorders in terms of the number of episodes of the behaviour.
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.
Time Frame
8 weeks
Title
Profile of Mood States (POMS)
Description
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:
Total Mood Disturbance [TMD] (-32 to 200)
Subscales:
Anger (0-48)
Confusion (0-28)
Depression (0-60)
Fatigue (0-28)
Tension (0-36)
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.
Time Frame
8 weeks
Title
State Anxiety Inventory (STAI) Short Form
Description
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.
Time Frame
8 weeks
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
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.
Time Frame
8 weeks
Title
Blood Pressure
Description
Investigators will use an automated sphygmomanometer to measure blood pressure during each of the 2 in-lab sessions.
Several measures will be collected:
MAP (mmHg)
Systolic pressure (mmHg)
Diastolic pressure (mmHg)
Time Frame
8 weeks
Title
Height (cm)
Description
Investigators will use a vertical scale via measuring tape to measure height (cm) during each of the 2 in-lab sessions.
Time Frame
8 weeks
Title
Weight (kg)
Description
Investigators will use an automated scale to measure weight (kg) during each of the 2 in-lab sessions.
Time Frame
8 weeks
Title
Waist Circumference (cm)
Description
Investigators will use a flexible measuring tape to measure waist circumference (cm) during each of the 2 in-lab sessions.
Time Frame
8 weeks
Title
Inflammatory Biomarker Interleukin-6 [IL6] (pg/mL)
Description
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.
Time Frame
8 weeks
Title
Inflammatory Biomarker Tumour Necrosis Factor Alpha [TNF-a] (pg/mL)
Description
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.
Time Frame
8 weeks
Title
Inflammatory Biomarker C-Reactive Protein [CRP] (mg/L)
Description
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.
Time Frame
8 weeks
Title
Blood Ketone Levels (mmol/L)
Description
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.
Time Frame
8 weeks
Title
Blood Glucose Levels (mmol/L)
Description
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.
Time Frame
8 weeks
Title
Body Composition (% Body Fat)
Description
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.
Time Frame
8 weeks
Title
Body Composition (Lean Body Mass - kg)
Description
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.
Time Frame
8 weeks
Title
Body Mass Index (BMI)
Description
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.
Time Frame
8 weeks
Title
Diet Satisfaction & Adherence Questionnaire
Description
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.
Time Frame
8 weeks
Title
Pregnancy Status
Description
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.
Time Frame
One time measure at Week 0
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Heisz, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
12. IPD Sharing Statement
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Intermittent Fasting Interventions on Brain Health in Women
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