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

NCT01495052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2011-12-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Yong Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-11-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495052 on ClinicalTrials.gov