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NCT Number: NCT02999867

Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes

This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

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Key information

Conditions

Type2 Diabetes Mellitus

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

About this study

The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients between the ages of 30 and 65 years
  • patients has been diagnosed as type 2 diabetes mellitus
  • Patients who like to be followed up for 2 months.

Exclusion criteria

  • Women in pregnancy or lactation.
  • Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.

Treatment and study plan

triticale and mung bean

Dietary Supplement

subjects are assigned to intake of triticale and mung bean for 30 days

Other names: M1 triticale and mung bean

adzuki bean

Dietary Supplement

subjects are assigned to intake of adzuki bean for 30 days

Other names: M2 adzuki bean

Primary outcomes

  1. response to the dietary intervention by the change from baseline in blood glucose at 30-day

    Time frame: baseline and 30 d

  2. response to the dietary intervention by the change from baseline in lipid profile at 30-day

    Time frame: baseline and 30 d

  3. response to the dietary intervention by the change from baseline in insulin resistance at 30-day

    Time frame: baseline and 30 d

Secondary outcomes

  1. response to the dietary intervention by the change from baseline in renal function at 30-day

    Time frame: baseline and 30 d

  2. response to the dietary intervention by the change from baseline in liver function at 30-day

    Time frame: baseline and 30 d

  3. response to the dietary intervention by the change from baseline in inflammation result at 30-day

    Time frame: baseline and 30 d

  4. response to the dietary intervention by the change from baseline in folic acid absorption at 30-day

    Time frame: baseline and 30 d

  5. response to the dietary intervention by the change from baseline in iron absorption at 30-day

    Time frame: baseline and 30 d

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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