Skip to main content
OpenTrials
Completed

NCT Number: NCT06560996

Very Low-calorie Diet & Cardiometabolic Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Fasting Feeding Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HC International SA

Weggis, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low calorie diet with low protein content (VLCD-LP group)

Other

Very low calorie diet (850 kcals per day) with low protein content (10%)

Very low calorie diet with high protein content (VLCD-HP group)

Other

Very low calorie diet (850 kcals per day) with high protein content (30%)

Primary outcomes

  1. Fasting blood glucose

    Time frame: 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 outcomes

  1. Measure circulatory autophagy marker Beclin-1

    Time frame: 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.

  2. Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3)

    Time frame: 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.

  3. Measure circulatory autophagy proteins (ATGs)

    Time frame: 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.

  4. Measure cardiometabolic health via insulin levels

    Time frame: 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.

  5. Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels

    Time frame: 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.

  6. Measure circulatory inflammation via C-reactive protein levels

    Time frame: 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.

  7. Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels

    Time frame: 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.

  8. Measure of cardiovascular health with blood pressure

    Time frame: 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).

  9. Functional measures of cardiovascular health

    Time frame: 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.

  10. Functional measures of cardiovascular health with heart rate

    Time frame: 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.

  11. Measures of cardiovascular health with autonomic function (blood pressure)

    Time frame: 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).

  12. Measures of cardiovascular health with autonomic function (heart rate)

    Time frame: 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).

  13. Body composition

    Time frame: 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).

  14. Faecal markers for gut microbiome diversity

    Time frame: 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)

  15. Urine markers of protein metabolism

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Chenot Group, HC International SA

Registry information

Official study title

Effects of Short-term Very Low-calorie Diets on Cardiometabolic Health Markers in Humans

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.