The Effect of Sea Buckthorn Extract in Patients With Type 1 Diabetes

NCT07787754 | Completed DMC

• 2 other identifiers: No. 1872022DKME202214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing β-cells by autoreactive T cells. Sea buckthorn (SBT), a traditional Chinese medicine homologous to food, confers beneficial effects on the autoimmune system. Whether SBT regulates the glucose metabolism and immune microenvironment in T1D remains unknown. This study aims to investigate the impact of SBT on glycemic control and T-cell balance in patients with T1D. Patients with T1D consumed 10g of SBT extracts daily for 12 weeks. Clinical and experimental data were analyzed at the baseline and after 12 weeks of SBT treatment. Healthy controls were enrolled with no treatment. Side adverse effects will be recorded in this study.

Conditions

Type 1 Diabetes

Keywords

Sea buckthorn extract; type 1 diabetes; T cell; islet β-cell; glucose metabolism

Outcome Measures

Primary Outcomes (1)

• Glucose control

  To investigate the effect of SBT on glucose metabolism in patients, fasting glucose level in mmol/L were measured after patients with T1D were administered a daily oral dose of 10g of SBT for 12 weeks.

  From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (1)

• T-cell population

  From enrollment to the end of treatment at 12 weeks.

Study Arms (2)

Healthy control

NO INTERVENTION

The healthy controls received no interventions.

Type 1 diabetes

EXPERIMENTAL

Patients received oral administration of 10g of SBT extracts daily, dissolved in 100 ml water at 40℃, taken before breakfast for 12 weeks, while continuing their current antihyperglycemic medication.

Dietary Supplement: Sea buckthorn

Interventions

Sea buckthorn DIETARY_SUPPLEMENT

Sea buckthorn extract One of the differences between these two studies and ours is that the SBT used in our study is extracted by supercritical extraction technology without additional components.

Type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Type 1 Diabetes Mellitus (T1DM) by an endocrinologist at a qualified medical institution.
• Aged between 18 and 75 years (inclusive).
• Maintained a stable anti-diabetic medication regimen for at least 3 months prior to enrollment and is expected to remain stable throughout the study duration.
• Glycated Hemoglobin A1c (HbA1c) ≤ 8%.

You may not qualify if:

• Patients with other types of diabetes (including Type 2 Diabetes, monogenic diabetes, diseases of the exocrine pancreas, and drug- or chemical-induced diabetes).
• History of acute metabolic events, specifically Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycemic State (HHS), within the past 6 months.
• Current use of medications that may affect immune function, including immunomodulatory or immunosuppressive treatment, steroids, or antibiotics in the previous 3 months.
• Pregnant or lactating women.
• Patients with abnormal renal function or abnormal liver function.
• Patients with malignant diseases.
• Patients with acute or chronic infection.
• Patients with a history of psychiatric or neurological disorders.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The first affiliated hospital of guangzhou medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaoyan Chen, Doctor

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 26, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)