Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes

NCT ID: NCT07329231

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-10
• Study Completion Date: 2025-12-30

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the quinoa diet (QD) group

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.

Group Type: EXPERIMENTAL

Quinoa-based foods

Intervention Type: DIETARY_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

the regular diet (RD) group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Quinoa-based foods

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

kuanxiao Tang

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao K Tang

Role: CONTACT

tangkx_ql@hotmail.com

008618560083053

Facility Contacts

Xiao K Tang

Role: primary

420247867@qq.com

0086053182166120

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

KYLL-2019(ZM)-062

Identifier Type: -

Identifier Source: org_study_id