The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

NCT04184440 | Unknown

• 1 other identifier: QQLY2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.

Conditions

Hyperglycemia

Keywords

Cyclocarya paliurus extract; hyperglycemia; pre-diabetes and diabetes

Outcome Measures

Primary Outcomes (4)

• changes of FPG

  fasting plasma glucose

  at 0 week，4th week and 12th week in the intervention period

• changes of HbA1c

  glycated hemoglobin

  at 0 week，4th week and 12th week in the intervention period

• changes of fasting insulin

  at 0 week，4th week and 12th week in the intervention period

• changes of OGTT

  oral glucose tolerance test

  at 0 week，4th week and 12th week in the intervention period

Secondary Outcomes (3)

• changes of blood lipids

  at 0 week，4th week and 12th week in the intervention period

• changes of gut microbiota

  at 0 week，4th week and 12th week in the intervention period

• changes of short chain fatty acids

  at 0 week，4th week and 12th week in the intervention period

Study Arms (3)

placebo

PLACEBO COMPARATOR

corn starch；capsule，2 g/day，2 times/day；3 months

Dietary Supplement: placebo

Cyclocarya paliurus extract

EXPERIMENTAL

aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months

Dietary Supplement: Cyclocarya paliurus extract

Cyclocarya paliurus compounds

EXPERIMENTAL

mixed aqueous extract of Cyclocarya paliurus and other traditional Chinese herbal medicines including Astragalus propinquus Schischkin，Dioscorea oppositifolia L.，Dendrobium nobile Lindl.，Salvia miltiorrhiza Bge. and Inulin；capsule，2 g/day，2 times/day；3 months

Dietary Supplement: Cyclocarya paliurus compounds

Interventions

Cyclocarya paliurus extract DIETARY_SUPPLEMENT

The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .

Cyclocarya paliurus extract

Cyclocarya paliurus compounds DIETARY_SUPPLEMENT

The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .

Cyclocarya paliurus compounds

placebo DIETARY_SUPPLEMENT

The participants are divided randomly into three groups，one of which are asked to take placebo for three months .

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol;
• age:20-65 years;
• BMI :20-35kg/m2.

You may not qualify if:

• type 1 diabetic patients;
• type 2 diabetic patients with insulin treatment；
• pregnant or lactating women；
• adverse effect on intervention；
• acute or chronic inflammatory conditions;
• severe hepatic,kidney or other complications;
• other situations ineligible to intervention.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Shiyan Taihe Hospital

Shiyan, Hubei, 442008, China

Location

MeSH Terms

Conditions

Hyperglycemia; Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Liegang Liu, PhD

CONTACT

+86-27-83650522; liegangliu@gmail.com

Hongjie Liu, master

CONTACT

D201981405@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The allocation of three groups is completed by the primary researcher,and unknown to participants and other reachers. It is the same in the size,color,shape and taste of capsules administrated by three groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 3, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)