None listed
Conditions
Brief summary
Subjects with obesity have an increased risk of type 2 diabetes and cardiovascular disease. The key mechanism unifying obesity and diabetes is insulin resistance. Lifestyle changes have been recognised to be fundamental to prevent diabetes and cardiovascular disease among obese people. In a previous investigation we have demonstrated that native banana starch (NBS) supplementation reduces body weight and insulin resistance in a group of obese diabetics. In the present study our aim is to investigate the effects of NBS when compared to metformin on a group of obese women at a high risk of chronic diseases. Metformin is known to possess an important insulin-sensitizing antidiabetic action.
Interventions
Forty obese women were selected and divided in two groups in a 2-arm parallel trial. Participants were randomly assigned to receive either 30 g of native banana starch (NBS) by day dissolved in 240 ml of water or metformin 850 mg/day. Each subject attended the laboratory on three occasions, once before any intervention, again following 4 weeks of intervention and the last at the end of the experimentation after 8 weeks of treatments. An oral glucose tolerance test (OGTT) was carried out before a
Forty obese women were selected and divided in two groups in a 2-arm parallel trial. Participants were randomly assigned to receive either 30 g of native banana starch (NBS) by day dissolved in 240 ml of water or metformin 850 mg/day. Each subject attended the laboratory on three occasions, once before any intervention, again following 4 weeks of intervention and the last at the end of the experimentation after 8 weeks of treatments. An oral glucose tolerance test (OGTT) was carried out before any intervention and after 8 weeks of experimentation. After 12 h fasting a 75g OGTT was performed according to the World Health Organization (WHO) criteria. Blood samples were taken at 0, 30, 60, 90 and 120 min after oral glucose for measuring glucose and insulin.
Sponsors
Universidad Juarez Autonoma de Mexico
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Female 2. Body Mass Index (BMI) >30 3.HOMA-Index > 2.5 4. Fast glycemia under 126 mg/dL 5. 2 h postprandial glycemia under 200 mg/dl 6. Have mantained stable weight during three months prior to experimentation 7. To be under the care of a health care provider from the Instituto Mexicano del Seguro Social (IMSS) 8. Available for the duration of the study.
Exclusion criteria
1.Inability to give informed consent 2. kidney or liver disease, 3. Diabetes mellitus 4.On psychiatric treatments 5. Smoker or alcoholic 6. Pregnant or receiving medical or naturist treatment to reduce body weight 7. Receiving hormonal therapy.
Outcome results
None listed