Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity

NACompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

December 31, 2023

Study Completion Date

August 31, 2024

Conditions
Obesity Adult Onset
Interventions
DIETARY_SUPPLEMENT

very low-calorie diet

Subjects undergo two cycles of a very-low-calorie diet (VLCD) for 6 weeks each, alternating with a hypocaloric diet (12 weeks). The dietetic intervention consists of a VLCD using a liquid formula (Optisource Plus, Nestlé S.A., Vevey, Switzerland), providing 52.8 g protein, 75.0 g carbohydrates, 13.5 g fat, 11.4 g fiber, and essential vitamins and minerals based on Recommended Dietary Allowances (RDA). This formula supplies 2738 kJ/day (654 kcal/day), replacing the participants' three daily meals. Following this and before the second VLCD cycle, a dietician performs an individualized nutritional assessment to calculate the resting energy expenditure, and personalized hypocaloric diets were prepared, reducing 500 kcal for each individual on their daily caloric expenditure, maintaining the recommended intake of each of the macronutrients (55% carbohydrates, 30% fats and 15% proteins) for 12-weeks.

Trial Locations (1)

46020

FISABIO, Valencia

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

lead

Celia Bañuls

OTHER

NCT06279780 - Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity | Biotech Hunter | Biotech Hunter