Very Low-calorie Diet & Cardiometabolic Health

University of Nottingham46 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

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 high protein content (VLCD-HP group)OTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

HC International SA

Weggis, Switzerland

Outcomes

Primary Outcomes

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

Time frame: Day 0, Day 8

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 0, Day 8

Measure circulatory inflammation via C-reactive protein levels

Data from ClinicalTrials.gov

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