Effect of red beetroot in subjects with pre-diabetes

Phase 3

Recruiting

Conditions: Prediabetes.
Impaired glucose tolerance (oral)
R73.02

Registration Number: IRCT20221220056876N1

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

Age 20-80 years old
BMI 18-35 kg/m2

Exclusion Criteria

People with type 1, type 2, or gestational diabetes mellitus
Use of any anti-diabetic agent except metformin
Taking medication that affects glucose metabolism such as glucocorticoids, less than eight weeks before the start of the study
Receiving growth hormone in less than six months before the start of the study
Allergy to beetroot consumption
A smoker or a history of smoking and alcohol consumption in the previous two years
History of cardiovascular diseases (open heart surgery, cardiac congestion, heart failure, and uncontrolled blood pressure), liver cirrhosis/liver transplant, and/or kidney disease (CKD)
History of inflammatory diseases such as rheumatoid arthritis
A history of hypothyroidism or hyperthyroidism
History of suffering from severe digestive diseases or mental illnesses
Having often physical activity (more than 5 hours a week)
Taking antioxidant supplements or hormonal treatments 4 weeks before the study
Pregnant or lactating women

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-hour blood glucose. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method.;Fasting blood sugar. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method.;Fasting insulin. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay.;Hemoglobin A1C. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method.;Homeostatic model assessment for insulin resistance. Timepoint: At the baseline and after 12 weeks. Method of measurement: Calculated by formula.;The quantitative insulin-sensitivity check index. Timepoint: At the baseline and after 12 weeks. Method of measurement: Calculated by formula.

Secondary Outcome Measures