None listed
Conditions
Brief summary
PROFASTA-2 is a sub study of the randomised, controlled, crossover the original PROFASTA trial. This study (PROFASTA-2) will compare two short fasting methods in healthy adults: a strict water-only fast and a vegetable-based fasting diet that provides very few calories from vegetables. By testing both approaches in the same group of participants, researchers hope to understand how each type of fasting affects the body at a physiological and cellular level. The proposed study hypothesis is that both fasting methods will trigger similar beneficial biological responses.
Interventions
Arm 1: 3-day water-only fasting (comparator)
Arm 2: 3-day vegetable fasting diet (VFD) (intervention).
Arm 2 consists of a 3.5-day plant-based fasting protocol providing no more than 25% of their daily caloric intake, sourced exclusively from non-starchy raw or cooked vegetables. All meals will be professionally prepared by an expert chef to ensure consistency and adherence. The diet is intentionally very low in protein and carbohydrates, and strictly excludes grains, legumes, and added fats.
Arm 1: 3-day water-only fasting (comparator) Arm 2: 3-day vegetable fasting diet (VFD) (intervention). Arm 2 consists of a 3.5-day plant-based fasting protocol providing no more than 25% of their daily caloric intake, sourced exclusively from non-starchy raw or cooked vegetables. All meals will be professionally prepared by an expert chef to ensure consistency and adherence. The diet is intentionally very low in protein and carbohydrates, and strictly excludes grains, legumes, and added fats. After completion of the intervention/comparator, and following the 4-week washout period, the two arms will be crossed over, and the intervention/comparator will be repeated. After 4 week wash out period, and before the second period of fasting, "Month 1" timepoint samples and data will be collected (baseline #2). Finally, 4 weeks after completion of the second bout of fasting, "Month 2" follow up timepoint samples and data will be collected. Adherence to the fasting intervention will be monitored via food diary and blood glucose and ketone monitoring. After each fasting period, participants will revert to their usual diets gradually, over the refeeding period of 4 days. The participants will be advised to start with low carbohydrate vegetable soup as their first meal and to consume a low carbohydrate vegetarian diet consisting of vegetables, salads, soups, and fruit for the first day. Participants will be advised to start with small portions and increase portion size gradually, returning to unrestricted/usual diets during the 4 day refeeding period. The diet will not be imposed or controlled, however, it will be documented via 4-day weighted food diary. Fasting will be carried out at home with daily clinic visit each morning. Adherence will be tracked by daily questionnaires, blood glucose and ketone measurements. The VFD meals will be collected from the clinic which will be prepared by the clinic Chef and comprised by the clinic Dietitian.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Disease status/ or disease group for study: healthy 2. Sex: male and female 3. Age range: 18-70 years old 4. BMI range: 20-40kg/m2 5. Basic written and spoken English language proficiency needed for the completion of the questionnaires. 6. Willing and able to undergo all study evaluations and adhere to fasting interventions. 7. Participation in the parent study ACTRN12623000087651 is also an inclusion criterion for eligibility for inclusion in this study,
Exclusion criteria
1. Participants that are pregnant, breastfeeding or of childbearing potential who are not willing to avoid becoming pregnant during the study. 2. History of chronic disease processes that according to the investigators could interfere with ability to undergo fasting or may affect the interpretation of results. 3. People with comorbidities such as (but not limited to) hypertension, diabetes, diagnosed cardiovascular disease 4. History of supplement and medication use that may affect the interpretation of results. 5. Health condition dietary requirements or life situation that would interfere with study participation and compliance. 6. Unintentional weight loss (>10% body weight) over the past 5 years, smoking, psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder). 7. People judged at the investigator’s discretion as being unsuitable to participate.
Outcome results
None listed