DiabetesNCT05756712

The Efficacy of White Kidney Bean on Oral Glucose Tolerance Test

A study testing Phase 1 Wonderlab Product and Phase 2 Wonderlab Product in people with Diabetes and Sugar; Blood, High, run by Shenzhen Precision Health Food Technology Co. Ltd., at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes, Sugar; Blood, High
What is being tested?: Phase 1 Wonderlab Product and Phase 2 Wonderlab Product
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteChina
Study dates: 6 Mar 2023to 31 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

SPRIM Central Lab
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Double-blind, Cross-over Clinical Trial of the Efficacy of White Kidney Bean on Oral Glucose Tolerance Test

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.

Conditions: Diabetes, Sugar; Blood, High
Being tested: Phase 1 Wonderlab Product, Phase 1 Placebo, Phase 2 Placebo, Phase 2 Wonderlab Product
Keywords: White Kidney Bean, Oral Glucose Tolerance Test
Medical subject headings: Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phase 1 Wonderlab ProductDietary supplement
Chew two tablets of Wonderlab Product for phase 1 (day 1)
Phase 1 PlaceboDietary supplement
Washout 72 hours and chew two tablets of placebo for phase 2 (day 4).
Phase 2 PlaceboDietary supplement
Chew two tablets of placebo for phase 1 (day 1)
Phase 2 Wonderlab ProductDietary supplement
Washout 72 hours and chew two tablets of Wonderlab Product for phase 2 (day 4).

Study groups in NCT05756712
Study group	Role	What they receive
Wonderlab Product plus Placebo	Active comparator	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 Receives: Dietary Supplement: Phase 1 Wonderlab Product; Dietary Supplement: Phase 1 Placebo
Placebo plus Wonderlab Product	Active comparator	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. Receives: Dietary Supplement: Phase 2 Placebo; Dietary Supplement: Phase 2 Wonderlab Product

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the end of Phase 1 and Phase 2 (each phase is 1 day)

Secondary outcomes (1)

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.
Measured: At the end of Phase 1 and Phase 2 (each phase is 1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 202331 Mar 2023

First posted6 Mar 2023
Study start6 Mar 2023
Primary completion15 Mar 2023
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05756712
Sponsor's protocol ID: 23-SM-02-WL-001
Status last verified: Apr 2023
First submitted: 20 Feb 2023
Last updated: 4 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Cross-over Clinical Trial of the Efficacy of White Kidney Bean on Oral Glucose Tolerance Test
ClinicalTrials.gov ID: NCT05756712
Acronym / sponsor ID: 23-SM-02-WL-001
Conditions: Diabetes, Sugar; Blood, High
Keywords: White Kidney Bean, Oral Glucose Tolerance Test
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,Other government
Study start: 6 Mar 2023 (actual)
Primary completion: 15 Mar 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 6 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Wonderlab Product plus Placebo	Active comparator	Dietary Supplement: Phase 1 Wonderlab Product, Dietary Supplement: Phase 1 PlaceboWonderlab 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 plus Wonderlab Product	Active comparator	Dietary Supplement: Phase 2 Placebo, Dietary Supplement: Phase 2 Wonderlab ProductPlacebo: 4g/tablet, per serving 750mg Maltodextrin Wonderlab product: White Kidney Bean Pressed Candy, 4g/tablet, per serving 750mg extracts of the white kidney bean.

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phase 1 Wonderlab ProductChew two tablets of Wonderlab Product for phase 1 (day 1)	Dietary supplement	Wonderlab Product plus Placebo
Phase 1 PlaceboWashout 72 hours and chew two tablets of placebo for phase 2 (day 4).	Dietary supplement	Wonderlab Product plus Placebo
Phase 2 PlaceboChew two tablets of placebo for phase 1 (day 1)	Dietary supplement	Placebo plus Wonderlab Product
Phase 2 Wonderlab ProductWashout 72 hours and chew two tablets of Wonderlab Product for phase 2 (day 4).	Dietary supplement	Placebo plus Wonderlab Product

Primary outcome

The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
Time frame: At the end of Phase 1 and Phase 2 (each phase is 1 day)
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.

1 secondary outcome

The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
Time frame: At the end of Phase 1 and Phase 2 (each phase is 1 day)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
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Type 2 Diabetes
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charlie Zhang, MD principal investigator

SPRIM Medical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phase 1 Wonderlab Product and Phase 2 Wonderlab Product in people with Diabetes and Sugar; Blood, High, run by Shenzhen Precision Health Food Technology Co. Ltd., at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention (time frame: At the end of Phase 1 and Phase 2 (each phase is 1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.