HealthyNCT06560996

Very Low-calorie Diet & Cardiometabolic Health

A study testing Very low calorie diet with low protein content (VLCD-LP group) and Very low calorie diet with high protein content (VLCD-HP group) in people with Healthy, run by University of Nottingham at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Very low calorie diet with low protein content (VLCD-LP group) and Very low calorie diet with high protein content (VLCD-HP group)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteSwitzerland
Study dates: 31 Jan 2024to 31 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

HC International SA
Weggis

Other trials in Switzerland

About this study

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

Read the 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).

Conditions: Healthy
Being tested: Very low calorie diet with low protein content (VLCD-LP group), Very low calorie diet with high protein content (VLCD-HP group)
Keywords: Fasting, Cardiometabolic health, Autophagy
Medical subject headings: Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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%)

Study groups in NCT06560996
Study group	Role	What they receive
Control	No intervention	7 days isoenergetic (weight maintaining) diet
Very low calorie diet with low protein content (VLCD-LP group)	Experimental	7 days very low-calorie diet (850 kcal per day) with low protein content (10% energy from protein, 45% from carbohydrate and 45% from plant-based fat) Receives: Other: Very low calorie diet with low protein content (VLCD-LP group)
Very low calorie diet with high protein content (VLCD-HP group)	Experimental	7 days very low-calorie diet with high protein content (30% energy from protein, 45% from carbohydrate and 25% from plant-based fat) Receives: Other: Very low calorie diet with high protein content (VLCD-HP group)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 0, Day 8

Secondary outcomes (15)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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
Measured: Day 0, Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202431 Jan 2025

First posted19 Aug 2024
Study start31 Jan 2024
Primary completion30 Sep 2024
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of NottinghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560996
Sponsor's protocol ID: FMHS 67-1123
Status last verified: Aug 2024
First submitted: 26 Jun 2024
Last updated: 30 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35764009
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.
PubMed 34040199
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.
PubMed 32729615
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.
PubMed 34135111
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.
PubMed 29193093
Burns L, Cooper S, Sarmad S, Funke G, Di Mauro A, Gaitanos GC, Tsintzas K. Effects of fasting-mimicking diets with low and high protein content on cardiometabolic health and autophagy: A randomized, parallel group study. Clin Nutr. 2025 Sep;52:299-312. doi: 10.1016/j.clnu.2025.08.004. Epub 2025 Aug 6.
PubMed 40816210

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Short-term Very Low-calorie Diets on Cardiometabolic Health Markers in Humans
ClinicalTrials.gov ID: NCT06560996
Acronym / sponsor ID: FMHS 67-1123
Conditions: Healthy
Keywords: Fasting, Cardiometabolic health, Autophagy
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of NottinghamUniversity, hospital or other
Collaborators: Chenot Group, HC International SA
Study start: 31 Jan 2024 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 19 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Control	No intervention	–7 days isoenergetic (weight maintaining) diet
Very low calorie diet with low protein content (VLCD-LP group)	Experimental	Other: Very low calorie diet with low protein content (VLCD-LP group)7 days very low-calorie diet (850 kcal per day) with low protein content (10% energy from protein, 45% from carbohydrate and 45% from plant-based fat)
Very low calorie diet with high protein content (VLCD-HP group)	Experimental	Other: Very low calorie diet with high protein content (VLCD-HP group)7 days very low-calorie diet with high protein content (30% energy from protein, 45% from carbohydrate and 25% from plant-based fat)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Very low calorie diet with low protein content (VLCD-LP group)Very low calorie diet (850 kcals per day) with low protein content (10%)	Other	Very low calorie diet with low protein content (VLCD-LP group)
Very low calorie diet with high protein content (VLCD-HP group)Very low calorie diet (850 kcals per day) with high protein content (30%)	Other	Very low calorie diet with high protein content (VLCD-HP group)

Primary outcome

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

15 secondary outcomes

Measure circulatory autophagy marker Beclin-1
Time frame: Day 0, Day 8
Measure circulatory autophagy marker Microtubule-associated protein 1A/1B-light chain 3 (LC3)
Time frame: Day 0, Day 8
Measure circulatory autophagy proteins (ATGs)
Time frame: Day 0, Day 8
Measure cardiometabolic health via insulin levels
Time frame: Day 0, Day 8
Measure circulatory inflammation via Insulin like-growth factor-1 (IGF-1) levels
Time frame: Day 0, Day 8
Measure circulatory inflammation via C-reactive protein levels
Time frame: Day 0, Day 8
Measure circulatory inflammation via Tumour Necrosis factor alpha-1 (TNF-alpha) levels
Time frame: Day 0, Day 8
Measure of cardiovascular health with blood pressure
Time frame: Day 0, Day 8
Functional measures of cardiovascular health
Time frame: Day 0, Day 8
Functional measures of cardiovascular health with heart rate
Time frame: Day 0, Day 8
Measures of cardiovascular health with autonomic function (blood pressure)
Time frame: Day 0, Day 8
Measures of cardiovascular health with autonomic function (heart rate)
Time frame: Day 0, Day 8
Body composition
Time frame: Day 0, Day 8
Faecal markers for gut microbiome diversity
Time frame: Day 0, Day 8
Urine markers of protein metabolism
Time frame: Day 0, Day 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Background: PubMed 35764009Wilhelmsen 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.
Background: PubMed 34040199Gao 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.
Background: PubMed 32729615Jones 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.
Background: PubMed 34135111Templeman 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.
Background: PubMed 29193093Gonzalez 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.
Derived from this study: PubMed 40816210Burns L, Cooper S, Sarmad S, Funke G, Di Mauro A, Gaitanos GC, Tsintzas K. Effects of fasting-mimicking diets with low and high protein content on cardiometabolic health and autophagy: A randomized, parallel group study. Clin Nutr. 2025 Sep;52:299-312. doi: 10.1016/j.clnu.2025.08.004. Epub 2025 Aug 6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kostas Tsintzas, PhD principal investigator

University of Nottingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting blood glucose (time frame: Day 0, Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560996, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.