Clinical trial NCT01495052: Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: naked oat (Avena nuda L.)
diabetes mellitus
RCT
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 445
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection
timeFrame: baseline, 30 days, 6 months and 1 year
measure: changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection
timeFrame: baseline, 30 days, 6 months and 1 year
Secondary outcomes:
measure: changs from baseline in plasma glucose
timeFrame: baseline, 30 days, 6 months and 1 year
measure: changes from baseline in lipid profile
timeFrame: baseline, 30 days, 6 months and 1 year
measure: changes from baseline in BMI
timeFrame: baseline, 30 days, 6 months and 1 year
measure: changes from baseline in plasma levels of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а
timeFrame: baseline and 30 days
measure: changes from baseline in WHR
timeFrame: baseline, 30 days, 6 months and 1 year
Other outcomes:
Locations:
city: Baotou
country: China
facility: Arms Industry New Century Hotel
state: Inner Mongolia Autonomous Region
Study officials:
References:
citation: Li X, Cai X, Ma X, Jing L, Gu J, Bao L, Li J, Xu M, Zhang Z, Li Y. Short- and Long-Term Effects of Wholegrain Oat Intake on Weight Management and Glucolipid Metabolism in Overweight Type-2 Diabetics: A Randomized Control Trial. Nutrients. 2016 Sep 7;8(9):549. doi: 10.3390/nu8090549.
citation: Gu J, Jing L, Ma X, Zhang Z, Xu M, Wang J, Li Y. Naked oat combined with a structured dietary intervention affects oxidative stress but not inflammation in diabetic dyslipidemia. Nutr Metab Cardiovasc Dis. 2014 Dec;24(12):e35-7. doi: 10.1016/j.numecd.2014.08.009. Epub 2014 Sep 16. No abstract available.
citation: Ma X, Gu J, Zhang Z, Jing L, Xu M, Dai X, Jiang Y, Li Y, Bao L, Cai X, Ding Y, Wang J, Li Y, Li Y. Effects of Avena nuda L. on metabolic control and cardiovascular disease risk among Chinese patients with diabetes and meeting metabolic syndrome criteria: secondary analysis of a randomized clinical trial. Eur J Clin Nutr. 2013 Dec;67(12):1291-7. doi: 10.1038/ejcn.2013.201. Epub 2013 Oct 16.