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.

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456347
• Other study ID #: PI19/485
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Obesity
• Overweight
• Overweight and Obesity
• PreDiabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Liver enzymes change.	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.	After 3 and 6 months of intervention.
Secondary	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.
Secondary	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.	After 3 and 6 months of intervention.
Secondary	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.
Secondary	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.