Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

May 8, 2014 updated by: Shaoguan University

Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes

Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shaoguan, Guangdong, China, 512005
        • Shaoguan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:

    (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;

  • Subject is between 18 and 75 years of age, inclusive.
  • Subject's BMI is >18.5 kg/m2 and <35 kg/m2.
  • If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

  • Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
  • Subject that use exogenous insulin for glucose control.
  • Subject that has a history of diabetic ketoacidosis.
  • Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
  • Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
  • Subject that has had operation less than six months prior to screening visit.
  • Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
  • Subject is known to be allergic or intolerant to any ingredient found in the study product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEHEL multi-nutrients supplement
75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.
Dietary supplement: LEHEL multi-nutrients supplement
The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.
No Intervention: Control
Received only oral hypoglycemic agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Control
Time Frame: Twelve weeks
Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaoguan University

Collaborators

Sun Yat-sen University

Investigators

  • Study Director: Wenhua Ling, Ph.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 7, 2013

First Submitted That Met QC Criteria

September 7, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGU-03
  • 2012BAD33B10 (Other Identifier: National Key Technology Research and Development Program of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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