Effects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms

A study testing Bashan and water in people with Type 2 Diabetes, run by Zhongda Hospital at 1 site in China.

Completed

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

Trial summary

The study aimed to observe the effect of targeted diet on blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring and to explore the possible mechanism of targeted diet on blood glucose improvement in type 2 diabetic patients. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Bashan and water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteChina
Study dates: 1 Mar 2021to 31 Dec 2022
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosed with type 2 diabetes;
With only diet and exercise control for at least 3 months or stable use of basal insulin for hypoglycemic treatment for at least 3 months;
Fasting blood glucose is greater than 7.0mmol/L, 2h postprandial blood glucose is greater than 11.1mmol/L, and glycosylated glycoprotein is 7.0-8.5%;
18-60 years old;
Those who have voluntarily signed the informed consent.

Who cannot join

Pregnant or lactating women or women planning pregnancy who are unwilling to take or do not take adequate contraceptive measures;
Drinking (more than 5 times a week, and 100g liquor or 250g yellow wine or 5 bottles of beer above on average each time) or smoking history;
Serious mental illness in the past 6 months;
Those who have undergone gastrointestinal surgery, except appendicitis and hernia surgery;
Patients with chronic or persistent hepatitis, patients with severe liver disease such as cirrhosis, or those whose hepatitis B surface antigen (HBsAg) is positive and is accompanied by abnormal liver function (serum glutamic pyruvic transaminase and aspartate aminotransferase are 2.5 times the normal value).
Suffering from Cushing's syndrome, pituitary dysfunction and other endocrine system diseases;

Show all 13Show fewer

Factors that hinder participation in the research, such as unstable medical conditions, including blood pressure and cardiovascular disease, etc.
malignant hypertension (blood pressure > 180/110mmHg, systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg); unstable blood pressure control; ii. myocardial infarction, other acute cardiac events requiring hospitalization, stroke, transient ischemic attack, or treatment of acute congestive heart failure;
Suffering from infectious diseases such as tuberculosis and AIDS;
Anemia: hemoglobin < 10g/dl;
Severe renal insufficiency: GFR ≤ 30ml/min/1.73m2;
Ketosis, ketoacidosis and uncontrolled infection in recent 1 month;
Those who are deemed unsuitable for participating in this clinical trial by the researcher for any reason;

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
Nanjing, Jiangsu

Other trials in China

About this study

Official title: Effects of Bashan,a Vegetable Plant Based Compound Drink , on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms

Read the detailed description

Subjects were studied on 2 occasions, separated by at least 7 days, in a randomized fashion. The order of the enteral infusions was randomized and facilitated by a biostatistician who generated the randomization code and a research officer who prepared the study solutions, but were not involved in data collection or analysis. Each occasion would last for 14 days maintaining daily eating habits without intervention and take 180ml mineral water or Bashan three times a day after meals. During the 2-week test, all subjects will still wear continuous glucose monitoring systems. Before and after the intervention, the standard meal test would be carried out on the subjects, and the samples of serum and feces, etc. of the subjects would be collected for the following tests.

Conditions: Type 2 Diabetes
Being tested: Bashan, water
Keywords: type 2 diabetes, glucose, TIR
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

BashanDietary supplement
a vegetable plant based compound drink add after three meals for 14 days
waterOther
water as placebo

Study groups in NCT05333822
Study group	Role	What they receive
Bashan	Experimental	a vegetable plant based compound drink add after three meals for 14 days Receives: Dietary Supplement: Bashan
Water	Placebo comparator	water as placebo Receives: Other: water

What is being measured

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

blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.
Measured: 14 days

Secondary outcomes (1)

insulin C-peptide gastric emptying
Measured: 14 days

Timeline

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

1 Mar 202131 Dec 2022

First posted19 Apr 2022
Study start1 Mar 2021
Primary completion28 Feb 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Type 2 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05333822
Sponsor's protocol ID: Bashan-01
Status last verified: Jan 2024
First submitted: 31 Mar 2022
Last updated: 25 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study didn't plan to share the data

Publications

Zhou M, Astell-Burt T, Bi Y, Feng X, Jiang Y, Li Y, Page A, Wang L, Xu Y, Wang L, Zhao W, Ning G. Geographical variation in diabetes prevalence and detection in china: multilevel spatial analysis of 98,058 adults. Diabetes Care. 2015 Jan;38(1):72-81. doi: 10.2337/dc14-1100. Epub 2014 Oct 28.
PubMed 25352654
Ji X, Leng XY, Dong Y, Ma YH, Xu W, Cao XP, Hou XH, Dong Q, Tan L, Yu JT. Modifiable risk factors for carotid atherosclerosis: a meta-analysis and systematic review. Ann Transl Med. 2019 Nov;7(22):632. doi: 10.21037/atm.2019.10.115.
PubMed 31930033
Karagodin VP, Sukhorukov VN, Orekhov AN, Yet SF, Sobenin IA. Atherosclerosis prevention: the role of special diets and functional food. Front Biosci (Elite Ed). 2020 Jan 1;12(1):95-101. doi: 10.2741/E859.
PubMed 31585871
Post RE, Mainous AG 3rd, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012 Jan-Feb;25(1):16-23. doi: 10.3122/jabfm.2012.01.110148.
PubMed 22218620
Legeay S, Rodier M, Fillon L, Faure S, Clere N. Epigallocatechin Gallate: A Review of Its Beneficial Properties to Prevent Metabolic Syndrome. Nutrients. 2015 Jul 7;7(7):5443-68. doi: 10.3390/nu7075230.
PubMed 26198245
Li K, Yao F, Xue Q, Fan H, Yang L, Li X, Sun L, Liu Y. Inhibitory effects against alpha-glucosidase and alpha-amylase of the flavonoids-rich extract from Scutellaria baicalensis shoots and interpretation of structure-activity relationship of its eight flavonoids by a refined assign-score method. Chem Cent J. 2018 Jul 12;12(1):82. doi: 10.1186/s13065-018-0445-y.
PubMed 30003449
Gu Y, Wang X, Li J, Zhang Y, Zhong H, Liu R, Zhang D, Feng Q, Xie X, Hong J, Ren H, Liu W, Ma J, Su Q, Zhang H, Yang J, Wang X, Zhao X, Gu W, Bi Y, Peng Y, Xu X, Xia H, Li F, Xu X, Yang H, Xu G, Madsen L, Kristiansen K, Ning G, Wang W. Analyses of gut microbiota and plasma bile acids enable stratification of patients for antidiabetic treatment. Nat Commun. 2017 Nov 27;8(1):1785. doi: 10.1038/s41467-017-01682-2.
PubMed 29176714
Chen C, Zeng Y, Xu J, Zheng H, Liu J, Fan R, Zhu W, Yuan L, Qin Y, Chen S, Zhou Y, Wu Y, Wan J, Mi M, Wang J. Therapeutic effects of soluble dietary fiber consumption on type 2 diabetes mellitus. Exp Ther Med. 2016 Aug;12(2):1232-1242. doi: 10.3892/etm.2016.3377. Epub 2016 May 20.
PubMed 27446349
Fan J, Johnson MH, Lila MA, Yousef G, de Mejia EG. Berry and Citrus Phenolic Compounds Inhibit Dipeptidyl Peptidase IV: Implications in Diabetes Management. Evid Based Complement Alternat Med. 2013;2013:479505. doi: 10.1155/2013/479505. Epub 2013 Aug 29.
PubMed 24069048

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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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Bashan,a Vegetable Plant Based Compound Drink , on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
ClinicalTrials.gov ID: NCT05333822
Acronym / sponsor ID: Bashan-01
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes, glucose, TIR
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Zhongda HospitalUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 19 Apr 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bashan	Experimental	Dietary Supplement: Bashana vegetable plant based compound drink add after three meals for 14 days
Water	Placebo comparator	Other: waterwater as placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Diagnosed with type 2 diabetes;
With only diet and exercise control for at least 3 months or stable use of basal insulin for hypoglycemic treatment for at least 3 months;
Fasting blood glucose is greater than 7.0mmol/L, 2h postprandial blood glucose is greater than 11.1mmol/L, and glycosylated glycoprotein is 7.0-8.5%;
18-60 years old;
Those who have voluntarily signed the informed consent.

Key exclusion criteria (13 listed)

Pregnant or lactating women or women planning pregnancy who are unwilling to take or do not take adequate contraceptive measures;
Drinking (more than 5 times a week, and 100g liquor or 250g yellow wine or 5 bottles of beer above on average each time) or smoking history;
Serious mental illness in the past 6 months;
Those who have undergone gastrointestinal surgery, except appendicitis and hernia surgery;
Patients with chronic or persistent hepatitis, patients with severe liver disease such as cirrhosis, or those whose hepatitis B surface antigen (HBsAg) is positive and is accompanied by abnormal liver function (serum glutamic pyruvic transaminase and aspartate aminotransferase are 2.5 times the normal value).

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
Bashana vegetable plant based compound drink add after three meals for 14 days	Dietary supplement	Bashan
waterwater as placebo	Other	Water

Primary outcome

blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.
Time frame: 14 days

1 secondary outcome

insulin C-peptide gastric emptying
Time frame: 14 days

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 25 Jan 2024.
Background: PubMed 25352654Zhou M, Astell-Burt T, Bi Y, Feng X, Jiang Y, Li Y, Page A, Wang L, Xu Y, Wang L, Zhao W, Ning G. Geographical variation in diabetes prevalence and detection in china: multilevel spatial analysis of 98,058 adults. Diabetes Care. 2015 Jan;38(1):72-81. doi: 10.2337/dc14-1100. Epub 2014 Oct 28.
Background: PubMed 31930033Ji X, Leng XY, Dong Y, Ma YH, Xu W, Cao XP, Hou XH, Dong Q, Tan L, Yu JT. Modifiable risk factors for carotid atherosclerosis: a meta-analysis and systematic review. Ann Transl Med. 2019 Nov;7(22):632. doi: 10.21037/atm.2019.10.115.
Background: PubMed 31585871Karagodin VP, Sukhorukov VN, Orekhov AN, Yet SF, Sobenin IA. Atherosclerosis prevention: the role of special diets and functional food. Front Biosci (Elite Ed). 2020 Jan 1;12(1):95-101. doi: 10.2741/E859.
Background: PubMed 22218620Post RE, Mainous AG 3rd, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012 Jan-Feb;25(1):16-23. doi: 10.3122/jabfm.2012.01.110148.
Background: PubMed 26198245Legeay S, Rodier M, Fillon L, Faure S, Clere N. Epigallocatechin Gallate: A Review of Its Beneficial Properties to Prevent Metabolic Syndrome. Nutrients. 2015 Jul 7;7(7):5443-68. doi: 10.3390/nu7075230.
Background: PubMed 30003449Li K, Yao F, Xue Q, Fan H, Yang L, Li X, Sun L, Liu Y. Inhibitory effects against alpha-glucosidase and alpha-amylase of the flavonoids-rich extract from Scutellaria baicalensis shoots and interpretation of structure-activity relationship of its eight flavonoids by a refined assign-score method. Chem Cent J. 2018 Jul 12;12(1):82. doi: 10.1186/s13065-018-0445-y.
Background: PubMed 29176714Gu Y, Wang X, Li J, Zhang Y, Zhong H, Liu R, Zhang D, Feng Q, Xie X, Hong J, Ren H, Liu W, Ma J, Su Q, Zhang H, Yang J, Wang X, Zhao X, Gu W, Bi Y, Peng Y, Xu X, Xia H, Li F, Xu X, Yang H, Xu G, Madsen L, Kristiansen K, Ning G, Wang W. Analyses of gut microbiota and plasma bile acids enable stratification of patients for antidiabetic treatment. Nat Commun. 2017 Nov 27;8(1):1785. doi: 10.1038/s41467-017-01682-2.
Background: PubMed 27446349Chen C, Zeng Y, Xu J, Zheng H, Liu J, Fan R, Zhu W, Yuan L, Qin Y, Chen S, Zhou Y, Wu Y, Wan J, Mi M, Wang J. Therapeutic effects of soluble dietary fiber consumption on type 2 diabetes mellitus. Exp Ther Med. 2016 Aug;12(2):1232-1242. doi: 10.3892/etm.2016.3377. Epub 2016 May 20.
Background: PubMed 24069048Fan J, Johnson MH, Lila MA, Yousef G, de Mejia EG. Berry and Citrus Phenolic Compounds Inhibit Dipeptidyl Peptidase IV: Implications in Diabetes Management. Evid Based Complement Alternat Med. 2013;2013:479505. doi: 10.1155/2013/479505. Epub 2013 Aug 29.
Individual participant dataSharing planned: No. The study didn't plan to share the data

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

Zilin Sun study chair

Zhongda Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Bashan and water in people with Type 2 Diabetes, run by Zhongda Hospital 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 5 inclusion and 13 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 25 Jan 2024. 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. Some participants in this study may receive a placebo. 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?

blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring. (time frame: 14 days). 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 NCT05333822, which also lists 9 linked publications.

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 25 Jan 2024.