Healthy
Conditions
Keywords
Fasting, Cardiometabolic health, Autophagy
Brief 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.
Detailed description
The aim of this project is to investigate the metabolic effects of a short-term (1-week) nutritional intervention in healthy humans using very low-calorie (fasting-mimicking) diets with low and high protein content on key cardiometabolic outcomes (with blood glucose as a primary outcome) and autophagy, oxidative stress, inflammation, functional measures of cardiovascular health, body composition, and faecal markers for gut microbiome diversity (secondary outcomes).
Interventions
OTHERVery low calorie diet with low protein content (VLCD-LP group)
Very low calorie diet (850 kcals per day) with low protein content (10%)
OTHERVery low calorie diet with high protein content (VLCD-HP group)
Very low calorie diet (850 kcals per day) with high protein content (30%)
Sponsors
Chenot Group, HC International SA
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study * Participant is willing and able to comply with the requirements of the study protocol * Aged between 18 and 65 years * Healthy individual
Exclusion criteria
* A BMI \<18 or \>35 kg/m2 * Regularly skipping breakfast * On an energy-restricted diet * Taking medication to control appetite * Eating Attitudes Test (EAT-26) score \>20 as self-reported marker of symptoms and concerns characteristic of eating disorders * Active metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure * Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | Day 0, Day 8 | To determine the impact of very low-calorie diets on fasting blood glucose concentration and the addition of low and high protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3) | Day 0, Day 8 | To determine the impact of very low-calorie diets with low and high protein content on LC3 measured using Western Blotting and PCR techniques. |
| Measure circulatory autophagy proteins (ATGs) | Day 0, Day 8 | 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. |
| Measure cardiometabolic health via insulin levels | Day 0, Day 8 | To determine the impact of very low-calorie diets with low and high protein content on insulin using enzyme linked immunosorbant assays. |
| Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels | Day 0, Day 8 | 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. |
| Measure circulatory inflammation via C-reactive protein levels | Day 0, Day 8 | 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. |
| Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels | Day 0, Day 8 | To determine the impact of very low-calorie diets with low and high protein content on serum TNFalpha levels using enzyme linked immunosorbant assays. |
| Measure of cardiovascular health with blood pressure | Day 0, Day 8 | 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). |
| Measure circulatory autophagy marker Beclin-1 | Day 0, Day 8 | 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. |
| Functional measures of cardiovascular health with heart rate | Day 0, Day 8 | To determine the impact of very low-calorie diets with low and high protein content on heart rate and heart rate variability. |
| Measures of cardiovascular health with autonomic function (blood pressure) | Day 0, Day 8 | 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). |
| Measures of cardiovascular health with autonomic function (heart rate) | Day 0, Day 8 | 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). |
| Body composition | Day 0, Day 8 | 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). |
| Faecal markers for gut microbiome diversity | Day 0, Day 8 | 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) |
| Urine markers of protein metabolism | Day 0, Day 8 | 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 |
| Functional measures of cardiovascular health | Day 0, Day 8 | 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. |
Countries
Switzerland
Outcome results
None listed