NCT06560996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 30, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

June 26, 2024

Last Update Submit

March 25, 2025

Conditions

Healthy

Keywords

FastingCardiometabolic healthAutophagy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Measure circulatory autophagy marker Beclin-1

    Day 0, Day 8

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

    Day 0, Day 8

  • Measure circulatory autophagy proteins (ATGs)

    Day 0, Day 8

  • Measure cardiometabolic health via insulin levels

    Day 0, Day 8

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

    Day 0, Day 8

  • +10 more secondary outcomes

Study Arms (3)

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)

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)

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

Interventions

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 low protein content (VLCD-LP group)
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%)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HC International SA

Weggis, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 35764009BACKGROUND

  • 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.

    PMID: 34040199BACKGROUND

  • 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.

    PMID: 32729615BACKGROUND

  • 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.

    PMID: 34135111BACKGROUND

  • 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.

    PMID: 29193093BACKGROUND

  • 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.

    PMID: 40816210DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Kostas Tsintzas, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Physiology

Study Record Dates

First Submitted

June 26, 2024

First Posted

August 19, 2024

Study Start

January 31, 2024

Primary Completion

September 30, 2024

Study Completion

January 31, 2025

Last Updated

March 30, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)