Very Low-calorie Diet & Cardiometabolic Health
NCT Number: NCT06560996
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Very low calorie diet with low protein content (VLCD-LP group)|OTHER: Very low calorie diet with high protein content (VLCD-HP group)
Sponsor: University of Nottingham
Collaborators: Chenot Group, HC International SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-31
Completion Date: 2025-01-31
Locations: HC International SA, Weggis, Switzerland

Summary:
To investigate the effects of a short-term (1-week) nutritional intervention in healthy individuals using very low-calorie (fasting-mimicking) diets with different protein content on markers of cardiometabolic health and autophagy.

Primary Outcome Measures: Fasting blood glucose, To determine the impact of very low-calorie diets on fasting blood glucose concentration and the addition of low and high protein, Day 0, Day 8
Secondary Outcome Measures: Measure circulatory autophagy marker Beclin-1, To determine the impact of very low-calorie diets with low and high protein content on Beclin-1 measured using Western Blotting and real-time polymerase chain reaction (PCR) techniques., Day 0, Day 8|Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3), To determine the impact of very low-calorie diets with low and high protein content on LC3 measured using Western Blotting and PCR techniques., Day 0, Day 8|Measure circulatory autophagy proteins (ATGs), To determine the impact of very low-calorie diets with low and high protein content on ATGs measured using Western Blotting and real-time PCR techniques., Day 0, Day 8|Measure cardiometabolic health via insulin levels, To determine the impact of very low-calorie diets with low and high protein content on insulin using enzyme linked immunosorbant assays., Day 0, Day 8|Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels, To determine the impact of very low-calorie diets with low and high protein content on serum IGF-1 levels using enzyme linked immunosorbant assays., Day 0, Day 8|Measure circulatory inflammation via C-reactive protein levels, To determine the impact of very low-calorie diets with low and high protein content on serum C-reactive protein levels using enzyme linked immunosorbant assays., Day 0, Day 8|Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels, To determine the impact of very low-calorie diets with low and high protein content on serum TNFalpha levels using enzyme linked immunosorbant assays., Day 0, Day 8|Measure of cardiovascular health with blood pressure, To determine the impact of very low-calorie diets with low and high protein content on supine and standing blood pressure (both diastolic and systolic)., Day 0, Day 8|Functional measures of cardiovascular health, To determine the impact of very low-calorie diets with low and high protein content on arterial stiffness using suprasternal notch-femoral pulse wave velocity by ArterioGraph., Day 0, Day 8|Functional measures of cardiovascular health with heart rate, To determine the impact of very low-calorie diets with low and high protein content on heart rate and heart rate variability., Day 0, Day 8|Measures of cardiovascular health with autonomic function (blood pressure), To determine the impact of very low-calorie diets with low and high protein content on autonomic function (blood pressure \[diastolic and systolic\] response to postural change and rhythmic breathing)., Day 0, Day 8|Measures of cardiovascular health with autonomic function (heart rate), To determine the impact of very low-calorie diets with low and high protein content on autonomic function (heart rate response to postural change and rhythmic breathing)., Day 0, Day 8|Body composition, To determine the impact of very low-calorie diets with low and high protein content on body fat mass and lean mass using DEXA (dual energy x-ray absorptiometry)., Day 0, Day 8|Faecal markers for gut microbiome diversity, To determine the impact of very low-calorie diets with low and high protein content on microbiome diversity using stool analysis techniques (16S Metagenomic Sequencing), Day 0, Day 8|Urine markers of protein metabolism, To determine the impact of very low-calorie diets with low and high protein content on urinary markers of protein metabolism (ratio of urea to creatinine) using established biochemical (spectrophotometric) methods, Day 0, Day 8