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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yong Li, Peking University
ClinicalTrials.gov Identifier:
NCT01495052
First received: December 9, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Dietary Supplement: organic naked oat with whole germ (ONOG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]
    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.

  • changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • changs from baseline in plasma glucose [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]
    Venous blood samples were collected for determination of fasting plasma glucose(FPG), postprandial blood glucose (PG).Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

  • changes from baseline in lipid profile [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]
    Venous blood samples were collected for determination of total triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c). Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

  • changes from baseline in BMI [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]
    Weight and height were measured at each time. BMI was calculated as weight divided by square height.Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

  • changes from baseline in plasma levels of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    Venous blood samples were collected for determination of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а. Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.

  • changes from baseline in WHR [ Time Frame: baseline, 30 days, 6 months and 1 year ] [ Designated as safety issue: No ]
    waist circumference and hip circumference were measured at each time. WHR was calculated as waist circumference divided by hip circumference.Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.


Enrollment: 445
Study Start Date: August 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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 Intervention: diet group
This group received systematic education about nutrition and diabetes combined with a structured dietary intervention.
Experimental: 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.
 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.
Other Name: organic naked oat with whole germ (ONOG),
Experimental: 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.
 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.
Other Name: organic naked oat with whole germ (ONOG),

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495052

Locations
China, Inner Mongolia Autonomous Region
Arms Industry New Century Hotel
Baotou, Inner Mongolia Autonomous Region, China, 014032
Sponsors and Collaborators
Yong Li
  More Information

No publications provided

Responsible Party: Yong Li, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01495052     History of Changes
Other Study ID Numbers: ONOG-0001, ONOG-0001-01
Study First Received: December 9, 2011
Last Updated: December 15, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
naked oat (Avena nuda L.)
diabetes mellitus
RCT

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013