Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus

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ÁllapotElkészült

Szponzorok

Yong Li

KLINIKAI VIZSGÁLAT: NCT01495052

BioSeek: nct01495052

Kulcsszavak

Absztrakt

Dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.

After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes. Participants would be randomly assigned to one of the four following groups: usual care group (only basic health advice, no other interventions), diet group (systematic education, structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes.

The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care.

Dátumok

Utolsó ellenőrzés:	11/30/2011
Első benyújtás:	12/08/2011
Becsült beiratkozás benyújtva:	12/14/2011
Első közzététel:	12/18/2011
Utolsó frissítés beküldve:	12/14/2011
Utolsó frissítés közzétéve:	12/18/2011
A tanulmány tényleges kezdési dátuma:	07/31/2011
Becsült elsődleges befejezési dátum:	10/31/2011

Állapot vagy betegség

Diabetes Mellitus

Beavatkozás / kezelés

Dietary Supplement: organic naked oat with whole germ (ONOG)

Fázis

Karcsoportok

Kar	Beavatkozás / kezelés
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.

Jogosultsági kritériumok

Tanulásra alkalmas korok	50 Years Nak nek 50 Years
Tanulásra alkalmas nemek	All
Egészséges önkénteseket fogad	Igen
Kritériumok	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.

Eredmény

Elsődleges eredménymérők

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]

Venous blood samples were collected for determination of glycosylated haemoglobin (HbA1c).Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

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]

Venous blood samples were collected for determination of serum insulin.Insulin resistance was measured by HOMO-IR, calculated with the following formula: HOMO-IR=Fasting serum insulin(μU/mL)*FPG(mmol/L)/22.5

Másodlagos eredménymérők

1. changs from baseline in plasma glucose [baseline, 30 days, 6 months and 1 year]

Venous blood samples were collected for determination of fasting plasma glucose(FPG), postprandial blood glucose (PG).Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

2. changes from baseline in lipid profile [baseline, 30 days, 6 months and 1 year]

Venous blood samples were collected for determination of total triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c). Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

3. changes from baseline in BMI [baseline, 30 days, 6 months and 1 year]

Weight and height were measured at each time. BMI was calculated as weight divided by square height.Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

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]

Venous blood samples were collected for determination of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а. Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

5. changes from baseline in WHR [baseline, 30 days, 6 months and 1 year]

waist circumference and hip circumference were measured at each time. WHR was calculated as waist circumference divided by hip circumference.Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus

Kulcsszavak

zab

diabetes mellitus type 2

cukorbetegség

inzulinrezisztencia

avena nuda

abrakzab