Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
Ключови думи
Резюме
Дати
Последна проверка: | 11/30/2011 |
Първо изпратено: | 12/08/2011 |
Очаквано записване подадено: | 12/14/2011 |
Първо публикувано: | 12/18/2011 |
Изпратена последна актуализация: | 12/14/2011 |
Последна актуализация публикувана: | 12/18/2011 |
Действителна начална дата на проучването: | 07/31/2011 |
Приблизителна дата на първично завършване: | 10/31/2011 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: organic naked oat with whole germ (ONOG)
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
No Intervention: Usual care group The usual care group was used as control group and didn't receive any intervention except standard health advice at the beginning and the end of the study. | |
No Intervention: diet group This group received systematic education about nutrition and diabetes combined with a structured dietary intervention. | |
Experimental: 50g-ONOG plus diet group This group received systematic education about nutrition and diabetes combined with a structured dietary intervention. Participants in the 50g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 50g ONOG. | |
Experimental: 100g-ONOG plus diet group This group received systematic education about nutrition and diabetes combined with a structured dietary intervention. Participants in the 100g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 100g ONOG. |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 50 Years Да се 50 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - all adults aged 50-65 years old with Type 2 Diabetes Mellitus - stable physical condition - fasting plasma glucose (FPG) concentration ≥7.8mmol/L or 2-h postprandial blood glucose (PG) ≥11.1mmol/L after 75g oral dextrose with an glycated hemoglobin (HbA1c)>7 %, stable medication. Exclusion Criteria: - pregnancy - breastfeeding - severe renal or hepatic complications - treatment by glucocorticoid - having pancreatic disease or malignancy in recent 3 months - other factors that may limit adherence to interventions or affect conduct of the trial or participation in another supplementary feeding programme. |
Резултат
Първични изходни мерки
1. change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection [baseline, 30 days, 6 months and 1 year]
2. changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection [baseline, 30 days, 6 months and 1 year]
Вторични изходни мерки
1. changs from baseline in plasma glucose [baseline, 30 days, 6 months and 1 year]
2. changes from baseline in lipid profile [baseline, 30 days, 6 months and 1 year]
3. changes from baseline in BMI [baseline, 30 days, 6 months and 1 year]
4. changes from baseline in plasma levels of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а [baseline and 30 days]
5. changes from baseline in WHR [baseline, 30 days, 6 months and 1 year]