Type 2 Diabetes Mellitus (T2DM)QIGMAGFBOβFIETNCT07329231
Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes
A study testing Quinoa-based foods in people with Type 2 Diabetes Mellitus (T2DM), run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to explore whether quinoa diet can improve glycolipid metabolism and glucose fluctuations in patients with early-stage type 2 diabetes mellitus (T2DM) and observe its impact on islet β-cell function and insulin resistance in patients with early-stage T2DM (diagnosed according to the… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Quinoa-based foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed according to the 1999 WHO diagnostic criteria for T2DM with a duration of less than 5 years HbA1c levels between 6.5% and 10% no history of insulin therapy age between 20 and 70 years. Exclusion Criteria： acute complications of diabetes, such as diabetic ketoacidosis severe acute or chronic conditions affecting the liver, kidneys, heart, cerebrovascular system, gastrointestinal tract, or acute infectious diseases pregnancy or plans for pregnancy soon allergies to quinoa or bean products participation in other dietary interventions or drug clinical trials within the past three months gastrointestinal diseases within two weeks prior to enrolment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Xiao K Tang, 0086053182166120, 420247867@qq.com
About this study
The goal of this clinical trial is to explore whether quinoa diet can improve glycolipid metabolism and glucose fluctuations in patients with early-stage type 2 diabetes mellitus (T2DM) and observe its impact on islet β-cell function and insulin resistance in patients with early-stage T2DM (diagnosed according to the 1999 WHO criteria, disease duration <5 years, HbA1c 6.5%-10%, no history of insulin therapy, aged 20-70 years).
The main question it aims to answer is:
Read more
Can quinoa diet reduce blood glucose (fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin), improve lipid metabolism (cholesterol, triglycerides), and stabilize glucose fluctuations (time in range, time above range) in patients with early-stage T2DM? Does quinoa diet improve islet β-cell function (HOMA-β) and insulin resistance (HOMA-IR), and reduce the need for oral hypoglycemic medications? Comparison group: Researchers will compare the quinoa diet (QD) group (replacing traditional starchy foods with quinoa products) vs. the regular diet (RD) group (conventional diet) to see if quinoa diet demonstrates better metabolic improvement and medication reduction effects.
Participants will:
Be randomly assigned to the QD group or RD group. Undergo oral glucose tolerance tests (OGTTs) and continuous glucose monitoring (cGMS) at baseline and after the intervention.
The QD group will consume quinoa-based foods (noodles, blended powder, cookies) as substitutes for staple foods, beverages, and snacks for 14 weeks, documenting daily intake in a record book.
Both groups will receive standardized dietary and exercise education, with monthly follow-ups for food distribution and data collection.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Quinoa-based foods
- Keywords
- Diabetes Mellitus, Quinoa Dietary Intervention, Glycaemic Fluctuations, Glycolipid metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinoa-based foodsDietary supplement
Quinoa-based foods included three varieties: quinoa noodles (80 g per bag; the ingredients included quinoa powder, red bean powder, black wheat powder, black mung bean powder, and edible salt, with quinoa powder comprising 15% of the total produced by Shandong Tangren Duoyi Biotechnology Company), blended powder (15 g per bag; the ingredients included quinoa, rye wheat, black mung beans, adzuki beans, black sesame seeds, chickpeas, konjac flour, and mogroside, with quinoa flour comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company), and cookies (24 g per bag; quinoa, rye, adzuki beans, black sesame seeds, vegetable oil, and salt, with quinoa comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company). These products serve as substitutes for the common starchy staples, soups, porridge, and snacks typically consumed by T2DM patients. This substitution did not alter patients' daily eating habits; rather, it simply replaced tradition
| Study group | Role | What they receive |
|---|---|---|
| the quinoa diet (QD) group | Experimental | The QD group replaced part of their staple foods with quinoa noodles, mixed flour, and biscuits. The intervention lasted for 14 weeks. Regular monitoring of indicators such as blood sugar, blood lipids, insulin resistance (HOMA-IR), and β-cell function (HOMA-β) was conducted, and the use of medications was recorded. Receives: Dietary Supplement: Quinoa-based foods |
| the regular diet (RD) group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability (MAGE) assessed by continuous glucose monitoring
Change from baseline to week 14 in Mean Amplitude of Glycemic Excursions (MAGE) calculated from 72-hour continuous glucose monitoring data.
Measured: From registration to the end of the 14-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Jan 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kuanxiao Tang, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329231
- Sponsor's protocol ID
- KYLL-2019(ZM)-062
- Acronym
- QIGMAGFBOβFIET
- Status last verified
- Dec 2025
- First submitted
- 1 Jun 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07329231
- Acronym / sponsor ID
- QIGMAGFBOβFIET / KYLL-2019(ZM)-062
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Diabetes Mellitus, Quinoa Dietary Intervention, Glycaemic Fluctuations, Glycolipid metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Jan 2026 (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.
The goal of this clinical trial is to explore whether quinoa diet can improve glycolipid metabolism and glucose fluctuations in patients with early-stage type 2 diabetes mellitus (T2DM) and observe its impact on islet β-cell function and insulin resistance in patients with early-stage T2DM (diagnosed according to the 1999 WHO criteria, disease duration <5 years, HbA1c 6.5%-10%, no history of insulin therapy, aged 20-70 years).
The main question it aims to answer is:
Can quinoa diet reduce blood glucose (fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin), improve lipid metabolism (cholesterol, triglycerides), and stabilize glucose fluctuations (time in range, time above range) in patients with early-stage T2DM? Does quinoa diet improve islet β-cell function (HOMA-β) and insulin resistance (HOMA-IR), and reduce the need for oral hypoglycemic medications? Comparison group: Researchers will compare the quinoa diet (QD) group (replacing traditional starchy foods with quinoa products) vs. the regular diet (RD) group (conventional diet) to see if quinoa diet demonstrates better metabolic improvement and medication reduction effects.
Participants will:
Be randomly assigned to the QD group or RD group. Undergo oral glucose tolerance tests (OGTTs) and continuous glucose monitoring (cGMS) at baseline and after the intervention.
The QD group will consume quinoa-based foods (noodles, blended powder, cookies) as substitutes for staple foods, beverages, and snacks for 14 weeks, documenting daily intake in a record book.
Both groups will receive standardized dietary and exercise education, with monthly follow-ups for food distribution and data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the quinoa diet (QD) group | Experimental | Dietary Supplement: Quinoa-based foodsThe QD group replaced part of their staple foods with quinoa noodles, mixed flour, and biscuits. The intervention lasted for 14 weeks. Regular monitoring of indicators such as blood sugar, blood lipids, insulin resistance (HOMA-IR), and β-cell function (HOMA-β) was conducted, and the use of medications was recorded. |
| the regular diet (RD) group | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed according to the 1999 WHO diagnostic criteria for T2DM with a duration of less than 5 years HbA1c levels between 6.5% and 10% no history of insulin therapy age between 20 and 70 years. Exclusion Criteria： acute complications of diabetes, such as diabetic ketoacidosis severe acute or chronic conditions affecting the liver, kidneys, heart, cerebrovascular system, gastrointestinal tract, or acute infectious diseases pregnancy or plans for pregnancy soon allergies to quinoa or bean products participation in other dietary interventions or drug clinical trials within the past three months gastrointestinal diseases within two weeks prior to enrolment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Quinoa-based foodsQuinoa-based foods included three varieties: quinoa noodles (80 g per bag; the ingredients included quinoa powder, red bean powder, black wheat powder, black mung bean powder, and edible salt, with quinoa powder comprising 15% of the total produced by Shandong Tangren Duoyi Biotechnology Company), blended powder (15 g per bag; the ingredients included quinoa, rye wheat, black mung beans, adzuki beans, black sesame seeds, chickpeas, konjac flour, and mogroside, with quinoa flour comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company), and cookies (24 g per bag; quinoa, rye, adzuki beans, black sesame seeds, vegetable oil, and salt, with quinoa comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company). These products serve as substitutes for the common starchy staples, soups, porridge, and snacks typically consumed by T2DM patients. This substitution did not alter patients' daily eating habits; rather, it simply replaced tradition | Dietary supplement | the quinoa diet (QD) group |
Primary outcome
Glucose variability (MAGE) assessed by continuous glucose monitoring
Time frame: From registration to the end of the 14-week treatment
Change from baseline to week 14 in Mean Amplitude of Glycemic Excursions (MAGE) calculated from 72-hour continuous glucose monitoring data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quinoa-based foods in people with Type 2 Diabetes Mellitus (T2DM), run by Qilu Hospital of Shandong University 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao K Tang (008618560083053, tangkx_ql@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose variability (MAGE) assessed by continuous glucose monitoring (time frame: From registration to the end of the 14-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.