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

Study Overview
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Brief Summary
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: organic naked oat with whole germ (ONOG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care group<br>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<br>This group received systematic education about nutrition and diabetes combined with a structured dietary intervention. | |
| Experimental: 50g-ONOG plus diet group<br>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. | Dietary Supplement: organic naked oat with whole germ (ONOG)<br>* The experimental product was ONOG (Inner Mongolia Sanzhuliang Natural Oats Industry Corporation), which was produced in the northwest part of China, applying with the organic standards. Participants in the 50g and 100g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 50g or 100g ONOG.<br>* Other names: organic naked oat with whole germ (ONOG),;|
| Experimental: 100g-ONOG plus diet group<br>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. | Dietary Supplement: organic naked oat with whole germ (ONOG)<br>* The experimental product was ONOG (Inner Mongolia Sanzhuliang Natural Oats Industry Corporation), which was produced in the northwest part of China, applying with the organic standards. Participants in the 50g and 100g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 50g or 100g ONOG.<br>* Other names: organic naked oat with whole germ (ONOG),;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection | 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. | baseline, 30 days, 6 months and 1 year | 
| changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection | 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 | baseline, 30 days, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changs from baseline in plasma glucose | 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. | baseline, 30 days, 6 months and 1 year | 
| changes from baseline in lipid profile | 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. | baseline, 30 days, 6 months and 1 year | 
| changes from baseline in BMI | 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. | baseline, 30 days, 6 months and 1 year | 
| changes from baseline in plasma levels of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а | 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. | baseline and 30 days | 
| changes from baseline in WHR | 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. | baseline, 30 days, 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naked oat (Avena nuda L.), diabetes mellitus, RCT