Trial · NCT05628727
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Depression, Anxiety and Stress Scale (DASS-21) Questionnaire - Stress Sub-Scale | 8 weeks | 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 | Colour and Word Stroop Test (SCWT) | 8 weeks | 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: 1. Stroop interference effect - the RT difference between incongruent and neutral trials 2. Stroop facilitation effect - the RT difference between the neutral and congruent trials |
| Secondary | Mnemonic Similarity Task (MST) | 8 weeks | 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'') |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 8 weeks | 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. |
| Secondary | Eating Disorder Examination Questionnaire (EDE-Q 6.0) | 8 weeks | 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. |
| Secondary | Profile of Mood States (POMS) | 8 weeks | 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. |
| Secondary | State Anxiety Inventory (STAI) Short Form | 8 weeks | 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. |
| Secondary | Five Facet Mindfulness Questionnaire (FFMQ) | 8 weeks | 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. |
| Secondary | Blood Pressure | 8 weeks | 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) |
| Secondary | Height (cm) | 8 weeks | Investigators will use a vertical scale via measuring tape to measure height (cm) during each of the 2 in-lab sessions. |
| Secondary | Weight (kg) | 8 weeks | Investigators will use an automated scale to measure weight (kg) during each of the 2 in-lab sessions. |
| Secondary | Waist Circumference (cm) | 8 weeks | Investigators will use a flexible measuring tape to measure waist circumference (cm) during each of the 2 in-lab sessions. |
| Secondary | Inflammatory Biomarker Interleukin-6 [IL6] (pg/mL) | 8 weeks | 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. |
| Secondary | Inflammatory Biomarker Tumour Necrosis Factor Alpha [TNF-a] (pg/mL) | 8 weeks | 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. |
| Secondary | Inflammatory Biomarker C-Reactive Protein [CRP] (mg/L) | 8 weeks | 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. |
| Secondary | Blood Ketone Levels (mmol/L) | 8 weeks | 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. |
| Secondary | Blood Glucose Levels (mmol/L) | 8 weeks | 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. |
| Secondary | Body Composition (% Body Fat) | 8 weeks | 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. |
| Secondary | Body Composition (Lean Body Mass - kg) | 8 weeks | 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. |
| Secondary | Body Mass Index (BMI) | 8 weeks | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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