Clinical trial NCT06560996: Very Low-calorie Diet & Cardiometabolic Health
Official title: Effects of Short-term Very Low-calorie Diets on Cardiometabolic Health Markers in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fasting
Cardiometabolic health
Autophagy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Chenot Group, HC International SA
First posted: 2024-08-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Day 0, Day 8
Secondary outcomes:
measure: Measure circulatory autophagy marker Beclin-1
timeFrame: Day 0, Day 8
measure: Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3)
timeFrame: Day 0, Day 8
measure: Measure circulatory autophagy proteins (ATGs)
timeFrame: Day 0, Day 8
measure: Measure cardiometabolic health via insulin levels
timeFrame: Day 0, Day 8
measure: Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels
timeFrame: Day 0, Day 8
measure: Measure circulatory inflammation via C-reactive protein levels
timeFrame: Day 0, Day 8
measure: Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels
timeFrame: Day 0, Day 8
measure: Measure of cardiovascular health with blood pressure
timeFrame: Day 0, Day 8
measure: Functional measures of cardiovascular health
timeFrame: Day 0, Day 8
measure: Functional measures of cardiovascular health with heart rate
timeFrame: Day 0, Day 8
measure: Measures of cardiovascular health with autonomic function (blood pressure)
timeFrame: Day 0, Day 8
measure: Measures of cardiovascular health with autonomic function (heart rate)
timeFrame: Day 0, Day 8
measure: Body composition
timeFrame: Day 0, Day 8
measure: Faecal markers for gut microbiome diversity
timeFrame: Day 0, Day 8
measure: Urine markers of protein metabolism
timeFrame: Day 0, Day 8
Other outcomes:
Locations:
city: Weggis
country: Switzerland
facility: HC International SA
Study officials:
affiliation: University of Nottingham
name: Kostas Tsintzas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilhelmsen A, Davies A, Mallinson J, Pabla P, Jones R, Palmer EA, Dunn WB, Moran GW, Stephens FB, Tsintzas K. Acute effects of prior dietary fat ingestion on postprandial metabolic responses to protein and carbohydrate co-ingestion in overweight and obese men: A randomised crossover trial. Clin Nutr. 2022 Aug;41(8):1623-1635. doi: 10.1016/j.clnu.2022.06.022. Epub 2022 Jun 16.
citation: Gao Y, Tsintzas K, Macdonald IA, Cordon SM, Taylor MA. Effects of intermittent (5:2) or continuous energy restriction on basal and postprandial metabolism: a randomised study in normal-weight, young participants. Eur J Clin Nutr. 2022 Jan;76(1):65-73. doi: 10.1038/s41430-021-00909-2. Epub 2021 May 26.
citation: Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.
citation: Templeman I, Smith HA, Chowdhury E, Chen YC, Carroll H, Johnson-Bonson D, Hengist A, Smith R, Creighton J, Clayton D, Varley I, Karagounis LG, Wilhelmsen A, Tsintzas K, Reeves S, Walhin JP, Gonzalez JT, Thompson D, Betts JA. A randomized controlled trial to isolate the effects of fasting and energy restriction on weight loss and metabolic health in lean adults. Sci Transl Med. 2021 Jun 16;13(598):eabd8034. doi: 10.1126/scitranslmed.abd8034.
citation: Gonzalez JT, Richardson JD, Chowdhury EA, Koumanov F, Holman GD, Cooper S, Thompson D, Tsintzas K, Betts JA. Molecular adaptations of adipose tissue to 6 weeks of morning fasting vs. daily breakfast consumption in lean and obese adults. J Physiol. 2018 Feb 15;596(4):609-622. doi: 10.1113/JP275113. Epub 2017 Dec 20.