The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention. To achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). The study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Diet was prescribed to the participant and menus and recipes were also provided.
Diet was prescribed to the participant and menus and recipes were also provided.
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, Spain
Glucose change.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Glycated hemoglobin change.
Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Insulin change.
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
HOMA-IR change.
HOMA-IR change assessed by difference in HOMA-IR concentration (absolute units and %) comparing 3 and 6 months visits with respect to baseline. HOMA-IR is calculated by calculating: \[(fasting glucose (mg/dL) x 0,0555) x fasting insulin (UI/ml)\] ÷ 22,5.
Time frame: After 3 and 6 months of intervention.
Body fat mass change.
Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Fat-free mass change.
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Visceral fat mass change.
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Total cholesterol change.
Total cholesterol change assessed by difference in fasting total cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
LDL cholesterol change.
Total LDL cholesterol change assessed by difference in fasting LDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
HDL cholesterol change.
HDL cholesterol change assessed by difference in fasting HDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
Triglycerides change.
Triglycerides change assessed by difference in fasting triglycerides concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Time frame: After 3 and 6 months of intervention.
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