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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-protein animal diet. | Experimental | Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein). |
|
| High-protein vegetal diet. | Experimental | Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-calorie and high-protein diet with the majority of protein coming from animal sources. | Behavioral | Diet was prescribed to the participant and menus and recipes were also provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose change. | Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline. | 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. | 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. | 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. | 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. | 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. | After 3 and 6 months of intervention. |
| Visceral fat mass change. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 and 6 months of intervention. |
| LDL cholesterol change. |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein change. | C-reactive protein change assessed by difference in fasting C-reactive protein concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| Liver enzymes change. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza | Zaragoza | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39420528 | Derived | Rodrigo-Carbo C, Madinaveitia-Nisarre L, Perez-Calahorra S, Gracia-Rubio I, Cebollada A, Galindo-Lalana C, Mateo-Gallego R, Lamiquiz-Moneo I. Low-calorie, high-protein diets, regardless of protein source, improve glucose metabolism and cardiometabolic profiles in subjects with prediabetes or type 2 diabetes and overweight or obesity. Diabetes Obes Metab. 2025 Jan;27(1):268-279. doi: 10.1111/dom.16013. Epub 2024 Oct 17. |
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| Low-calorie and high-protein diet with the majority of protein coming from plant sources. | Behavioral | Diet was prescribed to the participant and menus and recipes were also provided. |
|
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline. |
| After 3 and 6 months of intervention. |
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. |
| 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. | 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. | After 3 and 6 months of intervention. |
Liver enzymes (GGT, GOT and GPT) change assessed by difference in fasting liver enzymes concentration (U/L and %) comparing 3 and 6 months visits with respect to baseline.
| After 3 and 6 months of intervention. |
| Uric acid change. | Uric acid change assessed by difference in fasting uric acid concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| GLP-1 change. | GLP-1 change assessed by difference in fasting GLP-1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| GIP change. | GIP change assessed by difference in fasting GIP concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| IL-6 change. | IL-6 change assessed by difference in fasting IL-6 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| Leptin change. | Leptin change assessed by difference in fasting leptin concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| MCP1 change. | MCP1 change assessed by difference in fasting MCP1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| TNF-alpha change. | TNF-alpha change assessed by difference in fasting TNF-alpha concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline. | After 3 and 6 months of intervention. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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