Very Low-calorie Diet & Cardiometabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

7 days isoenergetic (weight maintaining) diet

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

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

Intervention Type 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)

7 days very low-calorie diet with high protein content (30% energy from protein, 45% from carbohydrate and 25% from plant-based fat)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

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

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes