Study of Oral Anthocyanins on Insulin Resistance
Nøgleord
Abstrakt
Datoer
| Sidst bekræftet: | 07/31/2019 |
| Først indsendt: | 08/10/2010 |
| Anslået tilmelding indsendt: | 08/10/2010 |
| Først indsendt: | 08/11/2010 |
| Sidste opdatering indsendt: | 07/31/2019 |
| Sidste opdatering indsendt: | 08/01/2019 |
| Faktisk startdato for undersøgelsen: | 05/31/2010 |
| Anslået primær afslutningsdato: | 04/30/2019 |
| Anslået afslutningsdato for undersøgelsen: | 04/30/2019 |
Tilstand eller sygdom
Intervention / behandling
Dietary Supplement: Mirtoselect
Fase
Armgrupper
| Arm | Intervention / behandling |
|---|---|
| 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. |
Kriterier for støtteberettigelse
| Alder berettiget til undersøgelse | 40 Years Til 40 Years |
| Køn, der er berettiget til undersøgelse | Male |
| Accepterer sunde frivillige | Ja |
| Kriterier | 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 |
Resultat
Primære resultatforanstaltninger
1. Oral Glucose Tolerance Test [Day 0 and 21 days post intervention]
Sekundære resultatforanstaltninger
1. Fasting blood glucose/insulin [Day 0, 7, 14, and 21 days post intervention]
