Dietary intervention trial: single blinded placebo-controlled, randomized study to assess anti-diabetic effects of daily bitter gourd consumption among pre-diabetics in Moshi, Tanzania
Not Applicable
- Conditions
- Pre-diabetes
- Registration Number
- DRKS00005131
- Lead Sponsor
- Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung (BMZ)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
BMI > 27 - < 35 kg/m²
-WC > 80 cm (women) > 94 cm (men)
-Being pre-diabetic according to:
-Fasting plasmae glucose (FPG) = 100 – 125 mg/dl (= 5.6 – 6.9 mmol/l) on two screening days or FPG = 100 – 125 mg/dl and HbA1c = 5.7% < 6.5% on one screening day
Exclusion Criteria
-Having diagnosed disease
-Having G6PD deficiency
-Taking any kind of medication regularly
-High blood pressure (>140/>90)
-Low blood pressure (<90/<60)
-Being mentally ill
-Pregnancy or planned pregnancy
-Breast-feeding
-Heavy alcohol consumption
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting plasma glucose: measured each at baseline and after each intervention of eight weeks (end assessment) as well as during the weekly check-ups.
- Secondary Outcome Measures
Name Time Method HbA1c, insulin, triglycerides, high-density lipoprotein, cholesterol:measured each at baseline and after each intervention of eight weeks (end assessment)<br>Body weight, waist circumference, blood pressure: measured each at baseline and after each intervention of eight weeks (end assessment) as well as during the weekly check-ups.