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NCT Number: NCT07787754

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of guangzhou medical University

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Glucose control

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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.

Secondary outcomes

  1. T-cell population

    Time frame: From enrollment to the end of treatment at 12 weeks.

    Fresh whole blood specimens were collected from patients with T1DM. T cell populations were analyzed on the flow cytometry.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Acronym: SBTT1D

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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