NCT04715776

Brief Summary

Investigators research team conducted a previous human clinical trial of brown algae and conducted liver and metabolic indicators of brown algae to improve nonalcoholic fatty liver disease, and found brown algae extract (LMF-HSFx, commodity In addition to reducing the liver function index, HbA1c in some patients with early stage diabetes or type 2 diabetes has an improved effect. In the mouse model of type 2 diabetes, comprehensive anti-hyperglycemia, anti-hyperlipidemia and hepatoprotective activity were studied using LMF-HSFx. Intake of LMF-HSFx reduced fasting blood glucose, increased adiponectin levels, reduced urine glucose, and improved hepatic glucose metabolism. LMF-HSFx can improve glucose and lipid metabolism in adipose tissue of diabetic mice, and inflammatory factors such as TNF-α and IL-6 can also be reduced. In this study,participants will be given Fuco-HiQ, and their effects on blood glucose and various metabolic indicators will be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

January 20, 2021

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

September 4, 2018

Last Update Submit

January 18, 2021

Conditions

Type II Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • From baseline to 3 months after using dietary supplements (compare yourself with yourself), follow up for a total of 12 months

    The change of HbA1c

    12 months

Study Arms (4)

Pre-DM patients with placebo

PLACEBO COMPARATOR

Pre-Diabetes patients uptake placebo as dietary supplement

Dietary Supplement: placebo

Pre-DM patients with supplement

EXPERIMENTAL

Pre-Diabetes patients uptake Brown seaweed as dietary supplement

Dietary Supplement: Brown seaweed

DM patients with placebo

PLACEBO COMPARATOR

Diabetes patients uptake placebo as dietary supplement.

Dietary Supplement: placebo

DM patients with supplement

EXPERIMENTAL

Diabetes patients uptake Brown seaweed as dietary supplement

Dietary Supplement: Brown seaweed

Interventions

Brown seaweedDIETARY_SUPPLEMENT

Uptake of 1650 mg brown seaweed product twice daily

DM patients with supplementPre-DM patients with supplement
placeboDIETARY_SUPPLEMENT

Uptake of 1650 mg placebo twice daily

DM patients with placeboPre-DM patients with placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 20 and 75 years old, biochemical test data and abdominal ultrasound screening were selected according to the following conditions.
  • Prediabetes: AC at 101 to 125 and HbA1c at 5.8 to 6.4 and abdominal ultrasound confirmed fatty liver.
  • Type 2 Diabetes: Abdominal ultrasound confirms the presence of fatty liver; Hypoglycemic agent HbA1c controls 8% (but does not contain Pioglitazone or injection of Liraglutide), or patient HbA1c is controlled below 9% but does not want to increase drug Dosage or add other hypoglycemic agents.

You may not qualify if:

  • Severe renal insufficiency (diabetic or eGFR less than 30 mL/min/1.73 m2), severe heart failure (NYHA function classification III or IV), etc.
  • Allergies to seafood and seaweed ingredients.
  • Cannot or refuse to sign test consent.
  • Inject insulin or Liraglutide or take Pioglitazone.
  • Type 1 diabetes patients.
  • People who drink alcohol and take weight-related drugs and health products.
  • There are blood transfusion recipients within three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wanfang Hospital

Taipei, Wenshan District, 116, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ming-Shun Wu

    Taipei Municipal Wanfang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

January 20, 2021

Study Start

December 10, 2018

Primary Completion

December 16, 2019

Study Completion

February 28, 2021

Last Updated

January 20, 2021

Record last verified: 2020-08

Locations

TW(1)