Effects of VLCKD in Metabolic Syndrome

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 7, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseObesityMetabolic Syndrome
Interventions
DIETARY_SUPPLEMENT

VLCKD diet with replacing meals

Patients will receive an accurate teaching + brochure on VLCKD diet from an expert dietician and freely receive the correct amount of supplements provided from Labotaoire Therascience (4 or 5 meals). The supplements contain (in total) between 600 and 800 kcal, mainly fats, 1,2/1,5 g/body weight of proteins, very low amount of charbohydrates (\<30/40g/die), 10-20g fibers, + minerals and vitamins covering the needings of patients. After 6-8 weeks, 1 meal will be replaced with a natural dish rich in proteins.

BEHAVIORAL

Hypocaloric mediterranean Diet

Patients will receive an accurate teaching + brochure on an hypocaloric Mediterranean style diet (LARN 2014) from an expert dietician. Patients will follow the istructions on grams and foods to eat. The calories will be around minus 400-500 kcal from energy requirement (measured by indirect calorimetry \* physical activity score).

Trial Locations (1)

28100

RECRUITING

: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont, Novara

All Listed Sponsors
collaborator

Laboratoire THERASCIENCE

UNKNOWN

lead

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

NCT05275608 - Effects of VLCKD in Metabolic Syndrome | Biotech Hunter | Biotech Hunter