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The Efficacy of White Kidney Bean on Oral Glucose Tolerance Test

Primary Purpose

Diabetes, Sugar; Blood, High

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phase 1 Wonderlab Product
Phase 1 Placebo
Phase 2 Placebo
Phase 2 Wonderlab Product
Sponsored by
Shenzhen Precision Health Food Technology Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring White Kidney Bean, Oral Glucose Tolerance Test

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults aged 25-45 years, with a male to female ratio of more than 40% and BMI 24. 35 subjects enrolled and 30 subjects completed the study; There is no history of diabetes and other metabolic syndrome, digestive diseases, endocrine disorder and mental diseases; No history of food allergy and intolerance; No nutritional supplements that affect glucose tolerance, oral contraceptives, acetylsalicylic acid, steroids, protease inhibitors, and antipsychotic drugs in the past 3 months; Able to tolerate at least 10 hours of fasting; Willing to refrain from participating in other interventional clinical studies during the trial period; Be able to fully understand the purpose, benefits and potential risks including side effects of the research; Willing to obey all test requirements and procedures; Informed consent signed. Exclusion Criteria: Subject who is in the treatment of gastrointestinal diseases; Subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.; Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months; Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation; Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment; Take laxatives or other substances that promote digestion 2 weeks before the trail start; Pregnant or lactating women or those planning to become pregnant during the trial; Liver function tests (alanine aminotransferase and aspartate aminotransferase), renal function tests (blood urea nitrogen and creatinine), routine blood tests, urinalysis, fecal occult blood test or electrocardiogram abnormalities.

Sites / Locations

  • SPRIM Central Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wonderlab Product plus Placebo

Placebo plus Wonderlab Product

Arm Description

Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean. Placebo: 4g/tablet, per serving 750mg Maltodextrin

Placebo: 4g/tablet, per serving 750mg Maltodextrin Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean.

Outcomes

Primary Outcome Measures

The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours.

Secondary Outcome Measures

The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours.

Full Information

First Posted
February 20, 2023
Last Updated
April 3, 2023
Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,
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1. Study Identification

Unique Protocol Identification Number
NCT05756712
Brief Title
The Efficacy of White Kidney Bean on Oral Glucose Tolerance Test
Official Title
A Randomized, Double-blind, Cross-over Clinical Trial of the Efficacy of White Kidney Bean on Oral Glucose Tolerance Test
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized, double-blind, cross-over inverventional study is to evaluate the efficacy of white kidney bean on OGTT (oral glucose tolerance test). About 34 eligible participants will be randomized in two groups of the same size to take the assigned interventions at one study site in Shanghai, two visits will be required. The first group of participants will take Wonderlab product first and then placebo product after 72 hours of washout period, while the other group of of participants will take placebo product first and then Wonderlab product after 72 hours of washout period. For each visit, the finger blood will be sampled and the relevent data such as blood glucose will be captured based on OGTT procedures, and recorded into clinical data management system for statistical analysis. Researchers will compare the two groups to see if there is significant change of blood glucose by using products containing ingredient of white kidney beans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Sugar; Blood, High
Keywords
White Kidney Bean, Oral Glucose Tolerance Test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wonderlab Product plus Placebo
Arm Type
Active Comparator
Arm Description
Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean. Placebo: 4g/tablet, per serving 750mg Maltodextrin
Arm Title
Placebo plus Wonderlab Product
Arm Type
Active Comparator
Arm Description
Placebo: 4g/tablet, per serving 750mg Maltodextrin Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean.
Intervention Type
Dietary Supplement
Intervention Name(s)
Phase 1 Wonderlab Product
Intervention Description
Chew two tablets of Wonderlab Product for phase 1 (day 1)
Intervention Type
Dietary Supplement
Intervention Name(s)
Phase 1 Placebo
Intervention Description
Washout 72 hours and chew two tablets of placebo for phase 2 (day 4).
Intervention Type
Dietary Supplement
Intervention Name(s)
Phase 2 Placebo
Intervention Description
Chew two tablets of placebo for phase 1 (day 1)
Intervention Type
Dietary Supplement
Intervention Name(s)
Phase 2 Wonderlab Product
Intervention Description
Washout 72 hours and chew two tablets of Wonderlab Product for phase 2 (day 4).
Primary Outcome Measure Information:
Title
The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
Description
The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours.
Time Frame
At the end of Phase 1 and Phase 2 (each phase is 1 day)
Secondary Outcome Measure Information:
Title
The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
Description
The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after intervention: Chewing Wonderlab Product - White Kidney Bean Pressed Candy, followed by Placebo Product at the interval of washout duration of 72 hours; and Chewing Placebo Product, followed by Wonderlab Product - White Kidney Bean Pressed Candy at the interval of washout duration of 72 hours.
Time Frame
At the end of Phase 1 and Phase 2 (each phase is 1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 25-45 years, with a male to female ratio of more than 40% and BMI 24. 35 subjects enrolled and 30 subjects completed the study; There is no history of diabetes and other metabolic syndrome, digestive diseases, endocrine disorder and mental diseases; No history of food allergy and intolerance; No nutritional supplements that affect glucose tolerance, oral contraceptives, acetylsalicylic acid, steroids, protease inhibitors, and antipsychotic drugs in the past 3 months; Able to tolerate at least 10 hours of fasting; Willing to refrain from participating in other interventional clinical studies during the trial period; Be able to fully understand the purpose, benefits and potential risks including side effects of the research; Willing to obey all test requirements and procedures; Informed consent signed. Exclusion Criteria: Subject who is in the treatment of gastrointestinal diseases; Subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.; Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months; Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation; Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment; Take laxatives or other substances that promote digestion 2 weeks before the trail start; Pregnant or lactating women or those planning to become pregnant during the trial; Liver function tests (alanine aminotransferase and aspartate aminotransferase), renal function tests (blood urea nitrogen and creatinine), routine blood tests, urinalysis, fecal occult blood test or electrocardiogram abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang, MD
Organizational Affiliation
SPRIM Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
SPRIM Central Lab
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of White Kidney Bean on Oral Glucose Tolerance Test

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