Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
NCT ID: NCT05456347
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2021-07-01
2022-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High-protein animal diet.
Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from animal sources (75% of total protein).
Low-calorie and high-protein diet with the majority of protein coming from animal sources.
Diet was prescribed to the participant and menus and recipes were also provided.
High-protein vegetal diet.
Low-calorie and high-protein diet (35% of total calories), mostly of protein coming from plant sources (75% of total protein).
Low-calorie and high-protein diet with the majority of protein coming from plant sources.
Diet was prescribed to the participant and menus and recipes were also provided.
Interventions
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Low-calorie and high-protein diet with the majority of protein coming from animal sources.
Diet was prescribed to the participant and menus and recipes were also provided.
Low-calorie and high-protein diet with the majority of protein coming from plant sources.
Diet was prescribed to the participant and menus and recipes were also provided.
Eligibility Criteria
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Inclusion Criteria
* BMI between 27.5 kg/m2 and 40 kg/m2.
* Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
* Informed consent to be signed.
Exclusion Criteria
* Taking lipid-lowering drugs in unstable dose in the previous 2 months.
* Taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight.
* Uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%)
* Any disease that could affect study results (i.e. uncontrolled hypothyroidism).
* Alcohol intake over 30 g/day.
* Pregnancy or breastfeeding.
* Any other condition that investigators consider that could interfere with study outcomes.
18 Years
80 Years
ALL
No
Sponsors
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Universidad de Zaragoza
OTHER
Responsible Party
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Rocio Mateo-Gallego
Principal Investigator
Locations
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Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, , Spain
Countries
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References
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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.
Other Identifiers
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PI19/485
Identifier Type: -
Identifier Source: org_study_id
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