Study of Oral Anthocyanins on Insulin Resistance
کلید واژه ها
خلاصه
تاریخ
آخرین تأیید شده: | 07/31/2019 |
اولین ارسال: | 08/10/2010 |
ثبت نام تخمینی ارسال شد: | 08/10/2010 |
اولین ارسال: | 08/11/2010 |
آخرین بروزرسانی ارسال شده: | 07/31/2019 |
آخرین به روزرسانی ارسال شده: | 08/01/2019 |
تاریخ شروع مطالعه واقعی: | 05/31/2010 |
تاریخ تخمین اولیه اولیه: | 04/30/2019 |
تاریخ برآورد مطالعه: | 04/30/2019 |
شرایط یا بیماری
مداخله / درمان
Dietary Supplement: Mirtoselect
فاز
گروههای بازو
بازو | مداخله / درمان |
---|---|
Active Comparator: Blaeberry concentrated caspule 30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.
Volunteers will be given a total daily dose of 1.4 grams of mirtoselect (a concentrated blaeberry extract) a day formulated in hard gelatin capsules (0.47 gram per capsule) administered thrice a day for 21 days.
Mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) | |
Placebo Comparator: Placebo capsules containing lactose 30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.
Volunteers will be given a placebo consisting of lactose formulated in hard gelatin capsules administered thrice a day for 21 days. |
معیارهای صلاحیت
سنین واجد شرایط تحصیل | 40 Years به 40 Years |
جنسیت واجد شرایط مطالعه | Male |
داوطلبان سالم را می پذیرد | آره |
شاخص | Inclusion Criteria: - Obese male subjects (BMI > 30) - Aged > 40 and < 70 years of age - Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance - All the obese subjects will have a waist circumference over 40 inches - All subjects must live the Aberdeenshire area of Scotland Exclusion Criteria: Medical exclusion criteria: - Chronic illness, including: - thromboembolic or coagulation disease, - unregulated thyroid disease, - kidney disease, - hepatic disease, - severe gastrointestinal disorders, - pulmonary disease (e.g. chronic bronchitis, COPD), - Alcohol or any other substance abuse, - Eating disorders, - Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders), - Skin conditions on the abdomen, - Allergy to skin dressings, Medication exclusion criteria: - Oral steroids, - Tricyclic antidepressants, neuroleptics, - Anticoagulants, - Digoxin and antiarrhythmics, - Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen), - Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin |
نتیجه
اقدامات اولیه
1. Oral Glucose Tolerance Test [Day 0 and 21 days post intervention]
اقدامات ثانویه
1. Fasting blood glucose/insulin [Day 0, 7, 14, and 21 days post intervention]