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

NCT01495052 | Completed

• 2 other identifiers: ONOG-0001ONOG-0001-01
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

naked oat (Avena nuda L.); diabetes mellitus; RCT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• changs from baseline in plasma glucose

  baseline, 30 days, 6 months and 1 year

• changes from baseline in lipid profile

  baseline, 30 days, 6 months and 1 year

• changes from baseline in BMI

  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

  baseline and 30 days

• changes from baseline in WHR

  baseline, 30 days, 6 months and 1 year

Study Arms (4)

Usual care group

NO INTERVENTION

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.

diet group

NO INTERVENTION

This group received systematic education about nutrition and diabetes combined with a structured dietary intervention.

50g-ONOG plus diet group

EXPERIMENTAL

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)

100g-ONOG plus diet group

EXPERIMENTAL

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)

Interventions

organic naked oat with whole germ (ONOG) DIETARY_SUPPLEMENT

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.

Also known as: organic naked oat with whole germ (ONOG),

100g-ONOG plus diet group; 50g-ONOG plus diet group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yong Li: lead

Study Sites (1)

Arms Industry New Century Hotel

Baotou, Inner Mongolia, 014032, China

Location

Related Publications (3)

• 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.

  PMID: 27618090 DERIVED

• 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.

  PMID: 25315670 DERIVED

• 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.

  PMID: 24129363 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 19, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2011
• Last Updated: December 19, 2011

Record last verified: 2011-12

Locations

CN (1)