Very Low-calorie Diet & Cardiometabolic Health

University of Nottingham

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06560996

FMHS 67-1123

Details and patient eligibility

About

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.

Full 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).

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 3 patient groups

Control

No Intervention group

Description:

7 days isoenergetic (weight maintaining) diet

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

Experimental group

Description:

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)

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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