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

Yong Li445 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

445

Conditions

Diabetes Mellitus

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Arms Industry New Century Hotel

Baotou, Inner Mongolia, China

Outcomes

Primary Outcomes

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.