LivingGLP1
Study S002659

Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients With Metabolic Syndrome

ClinicalTrials.gov record

Registration

Registration
NCT05275608
Acronym
KETO-MI
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Status
ACTIVE_NOT_RECRUITING
Enrollment
40
Start
2022-11-07
Primary completion
2026-01-31
Lead sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Conditions
Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome
Interventions
DIETARY_SUPPLEMENT:VLCKD diet with replacing meals; BEHAVIORAL:Hypocaloric mediterranean Diet
Results posted
FALSE

Registered primary outcomes

  • Change in weight [Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days]
  • Change in body circumferences [Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days]
  • Change in metabolic control [Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days]
  • Change in metabolic control [Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days]

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