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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: organic naked oat with whole germ (ONOG)

• Study Type: Interventional
• Enrollment (Actual): 445
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Inner Mongolia Autonomous Region
    • Baotou, Inner Mongolia Autonomous Region, China, 014032
      • Arms Industry New Century Hotel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: organic naked oat with whole germ (ONOG); 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.; Other Names: organic naked oat with whole germ (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.	Dietary supplement: organic naked oat with whole germ (ONOG); 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.; Other Names: organic naked oat with whole germ (ONOG),

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yong Li

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: RCT; diabetes mellitus; naked oat (Avena nuda L.)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: ONOG-0001; ONOG-0001-01 (Other Identifier: Beijing Nutrition society)