Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
NCT ID: NCT01495052
Last Updated: 2011-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
445 participants
INTERVENTIONAL
2011-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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 interventions assigned to this group
diet group
This group received systematic education about nutrition and diabetes combined with a structured dietary intervention.
No interventions assigned to this group
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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
65 Years
ALL
No
Sponsors
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Yong Li
OTHER
Responsible Party
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Yong Li
Professor
Locations
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Arms Industry New Century Hotel
Baotou, Inner Mongolia, China
Countries
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References
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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.
Other Identifiers
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ONOG-0001-01
Identifier Type: OTHER
Identifier Source: secondary_id
ONOG-0001
Identifier Type: -
Identifier Source: org_study_id