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.

Sponsor

Universidad de Zaragoza (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05456347

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Overweight and Obesity PreDiabetes	Behavioral: Low-calorie and high-protein diet with the majority of protein coming from animal sources. Behavioral: Low-calorie and high-protein diet with the majority of protein coming from plant sources.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: 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.
Experimental: 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).	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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).

Behavioral: 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.

Experimental: 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).

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Glucose change. [After 3 and 6 months of intervention.]
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Glycated hemoglobin change. [After 3 and 6 months of intervention.]
Glycated hemoglobin change assessed by difference in glycated hemoglobin concentration (%) comparing 3 and 6 months visits with respect to baseline.
Insulin change. [After 3 and 6 months of intervention.]
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 and 6 months visits with respect to baseline.
HOMA-IR change. [After 3 and 6 months of intervention.]
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.
Body fat mass change. [After 3 and 6 months of intervention.]
Body fat mass change assessed by difference in fat mass (%) comparing 3 and 6 months visits with respect to baseline.
Fat-free mass change. [After 3 and 6 months of intervention.]
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 and 6 months visits with respect to baseline.
Visceral fat mass change. [After 3 and 6 months of intervention.]
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 and 6 months visits with respect to baseline.

Secondary Outcome Measures

Total cholesterol change. [After 3 and 6 months of intervention.]
Total cholesterol change assessed by difference in fasting total cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
LDL cholesterol change. [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.
HDL cholesterol change. [After 3 and 6 months of intervention.]
HDL cholesterol change assessed by difference in fasting HDL cholesterol concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
Triglycerides change. [After 3 and 6 months of intervention.]
Triglycerides change assessed by difference in fasting triglycerides concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.

Other Outcome Measures

C-reactive protein change. [After 3 and 6 months of intervention.]
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.
Liver enzymes change. [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.
Uric acid change. [After 3 and 6 months of intervention.]
Uric acid change assessed by difference in fasting uric acid concentration (mg/dL and %) comparing 3 and 6 months visits with respect to baseline.
GLP-1 change. [After 3 and 6 months of intervention.]
GLP-1 change assessed by difference in fasting GLP-1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.
GIP change. [After 3 and 6 months of intervention.]
GIP change assessed by difference in fasting GIP concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.
IL-6 change. [After 3 and 6 months of intervention.]
IL-6 change assessed by difference in fasting IL-6 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.
Leptin change. [After 3 and 6 months of intervention.]
Leptin change assessed by difference in fasting leptin concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.
MCP1 change. [After 3 and 6 months of intervention.]
MCP1 change assessed by difference in fasting MCP1 concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.
TNF-alpha change. [After 3 and 6 months of intervention.]
TNF-alpha change assessed by difference in fasting TNF-alpha concentration (pg/mL and %) comparing 3 and 6 months visits with respect to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.