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Intermittent Fasting for Stress Management in Women

N/A
Waitlist Available
Led By Jennifer J Heisz, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will study how two fasting diets affect stress levels in adult women. Mental & physical health monitored via surveys & tests.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the fasting interventions may include hunger pangs, irritability due to hunger, headaches initially as the body adjusts to new eating patterns; however specific side effects will be monitored through surveys and health checks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale
Secondary outcome measures
Blood Glucose Levels (mmol/L)
Blood Ketone Levels (mmol/L)
Blood Pressure
+18 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Time-Restricted Feeding GroupExperimental Treatment1 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 GroupExperimental Treatment1 Intervention
This group will use the 5:2 method and fast for two non-consecutive days of the week.
Group III: Control GroupActive Control1 Intervention
This group will not fast.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,220 Total Patients Enrolled
Natural Sciences and Engineering Research Council, CanadaOTHER
58 Previous Clinical Trials
3,005 Total Patients Enrolled
Jennifer J Heisz, PhDPrincipal InvestigatorMcMaster University

Media Library

5:2 Fasting Clinical Trial Eligibility Overview. Trial Name: NCT05628727 — N/A
Stress Research Study Groups: 5:2 Fasting Group, Time-Restricted Feeding Group, Control Group
Stress Clinical Trial 2023: 5:2 Fasting Highlights & Side Effects. Trial Name: NCT05628727 — N/A
5:2 Fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628727 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants meet in order to enroll in this experiment?

"For this trial, 96 young adults aged 18-30 who are suffering from psychological stress must be recruited. Additionally, they need to have a normal BMI (18.5 - 24.9 kg/m^2), identify as female at birth, understand English, not engage in excessive physical activity or smoke cigarettes and consume no more than one alcoholic beverage daily with moderate to high levels of stress indicated by a score of 19+ on the DASS-21 questionnaire's stress subset."

Answered by AI

Is the current protocol for this research study allowing those over 45 to participate?

"The ideal participant for this medical experiment resides in the age range between 18 and 30 years old."

Answered by AI

Is recruitment for the trial still open to participants?

"According to records on clinicaltrials.gov, this medical trial is not presently enrolling members as it was last edited on the 16th of November 2022. Nonetheless, there are 107 other trials that remain open for recruitment at present."

Answered by AI
~0 spots leftby May 2024