Clinical trial NCT05756712: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Sugar; Blood, High
Keywords: White Kidney Bean
Oral Glucose Tolerance Test
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Sponsor class: OTHER_GOV
First posted: 2023-03-06
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The Change of Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
timeFrame: At the end of Phase 1 and Phase 2 (each phase is 1 day)
Secondary outcomes:
measure: The Change of Fast Blood Glucose Level in mmol/L based on OGTT (Oral Glucose Tolerance Test) after Intervention
timeFrame: At the end of Phase 1 and Phase 2 (each phase is 1 day)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: SPRIM Central Lab
state: Shanghai
Study officials:
affiliation: SPRIM Medical
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: