Clinical trial NCT05628727: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychological Stress
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2022-11-29
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Colour and Word Stroop Test (SCWT)
timeFrame: 8 weeks
measure: Mnemonic Similarity Task (MST)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: Eating Disorder Examination Questionnaire (EDE-Q 6.0)
timeFrame: 8 weeks
measure: Profile of Mood States (POMS)
timeFrame: 8 weeks
measure: State Anxiety Inventory (STAI) Short Form
timeFrame: 8 weeks
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Height (cm)
timeFrame: 8 weeks
measure: Weight (kg)
timeFrame: 8 weeks
measure: Waist Circumference (cm)
timeFrame: 8 weeks
measure: Inflammatory Biomarker Interleukin-6 [IL6] (pg/mL)
timeFrame: 8 weeks
measure: Inflammatory Biomarker Tumour Necrosis Factor Alpha [TNF-a] (pg/mL)
timeFrame: 8 weeks
measure: Inflammatory Biomarker C-Reactive Protein [CRP] (mg/L)
timeFrame: 8 weeks
measure: Blood Ketone Levels (mmol/L)
timeFrame: 8 weeks
measure: Blood Glucose Levels (mmol/L)
timeFrame: 8 weeks
measure: Body Composition (% Body Fat)
timeFrame: 8 weeks
measure: Body Composition (Lean Body Mass - kg)
timeFrame: 8 weeks
measure: Body Mass Index (BMI)
timeFrame: 8 weeks
measure: Diet Satisfaction & Adherence Questionnaire
timeFrame: 8 weeks
measure: Pregnancy Status
timeFrame: One time measure at Week 0
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jennifer J Heisz, PhD
role: PRINCIPAL_INVESTIGATOR
References: