Clinical trial NCT05456347: 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.
Official title: A Randomized Study to Investigate the 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Overweight and Obesity
PreDiabetes
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 80.
* 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 antidiabetic drugs (except for metformin with stable dose in the previous 6 months).
* 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.

Primary outcomes:
measure: Glucose change.
timeFrame: After 3 and 6 months of intervention.
measure: Glycated hemoglobin change.
timeFrame: After 3 and 6 months of intervention.
measure: Insulin change.
timeFrame: After 3 and 6 months of intervention.
measure: HOMA-IR change.
timeFrame: After 3 and 6 months of intervention.
measure: Body fat mass change.
timeFrame: After 3 and 6 months of intervention.
measure: Fat-free mass change.
timeFrame: After 3 and 6 months of intervention.
measure: Visceral fat mass change.
timeFrame: After 3 and 6 months of intervention.
Secondary outcomes:
measure: Total cholesterol change.
timeFrame: After 3 and 6 months of intervention.
measure: LDL cholesterol change.
timeFrame: After 3 and 6 months of intervention.
measure: HDL cholesterol change.
timeFrame: After 3 and 6 months of intervention.
measure: Triglycerides change.
timeFrame: After 3 and 6 months of intervention.
Other outcomes:
measure: C-reactive protein change.
timeFrame: After 3 and 6 months of intervention.
measure: Liver enzymes change.
timeFrame: After 3 and 6 months of intervention.
measure: Uric acid change.
timeFrame: After 3 and 6 months of intervention.
measure: GLP-1 change.
timeFrame: After 3 and 6 months of intervention.
measure: GIP change.
timeFrame: After 3 and 6 months of intervention.
measure: IL-6 change.
timeFrame: After 3 and 6 months of intervention.
measure: Leptin change.
timeFrame: After 3 and 6 months of intervention.
measure: MCP1 change.
timeFrame: After 3 and 6 months of intervention.
measure: TNF-alpha change.
timeFrame: After 3 and 6 months of intervention.
Locations:
city: Zaragoza
country: Spain
facility: Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Study officials:
References: