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

Yong Li

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: organic naked oat with whole germ (ONOG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01495052

ONOG-0001

ONOG-0001-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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445 participants in 4 patient groups

Usual care group

No Intervention group

Description:

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 group

Description:

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

50g-ONOG plus diet group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: organic naked oat with whole germ (ONOG)

100g-ONOG plus diet group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: organic naked oat with whole germ (ONOG)