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Status unknownNCT04715776Updated Jan 20, 2021

Supplementation of Brown Seaweed on Insulin Resistance of NAFLD Patients With Pre- or Type 2-Diabetes

An interventional study of Brown seaweed and placebo in Type II Diabetes, sponsored by Taipei Medical University WanFang Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Brown seaweeds rich in flavonoids and bioactive polysaccharides have been shown the potential effects on suppressing fat accumulation, oxidative stress and inflammation in liver. The refined seaweed compounds such as low-molecular-weight-fucoidan (LMF) and high stability fucoxanthin (HSFx), have not been well studied for its biological function.

The high stability fucoxanthin (HSFx) and the low-molecular-weight fucoidan (LMF) were produced by HiQ Marine Biotech Company in Taiwan. Study use fucoidan-fucoxanthin mixture (abbreviated as LMF-HSFx, each capsule contains 275 mg LMF and 275 mg HSFx).

Insulin resistance has a high correlation with fatty liver. Our 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.

Based on these studies, we hope to further explore whether LMF-HSFx can improve insulin resistance and thus assist blood glucose control.In this study,subjects will be given Fuco-HiQ, and their effects on blood glucose and various metabolic indicators will be evaluated.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 106 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Between the ages of 20 and 75 years old, biochemical test data and abdominal ultrasound screening were selected according to the following conditions.

  1. Prediabetes: AC at 101 to 125 and HbA1c at 5.8 to 6.4 and abdominal ultrasound confirmed fatty liver.
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Severe renal insufficiency (diabetic or eGFR less than 30 mL/min/1.73 m2), severe heart failure (NYHA function classification III or IV), etc.
  2. Allergies to seafood and seaweed ingredients.
  3. Cannot or refuse to sign test consent.
  4. Inject insulin or Liraglutide or take Pioglitazone.
  5. Type 1 diabetes patients.
  6. People who drink alcohol and take weight-related drugs and health products.
  7. There are blood transfusion recipients within three months.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Placebo comparator
    Pre-DM patients with placebo

    Pre-Diabetes patients uptake placebo as dietary supplement

    Dietary Supplement: placebo

  • Experimental
    Pre-DM patients with supplement

    Pre-Diabetes patients uptake Brown seaweed as dietary supplement

    Dietary Supplement: Brown seaweed

  • Placebo comparator
    DM patients with placebo

    Diabetes patients uptake placebo as dietary supplement.

    Dietary Supplement: placebo

  • Experimental
    DM patients with supplement

    Diabetes patients uptake Brown seaweed as dietary supplement

    Dietary Supplement: Brown seaweed

Interventions

  • Dietary supplementBrown seaweed

    Uptake of 1650 mg brown seaweed product twice daily

  • Dietary supplementplacebo

    Uptake of 1650 mg placebo twice daily

06

What researchers measure

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

    Time frame: 12 months

07

Study locations

1 site
  • Wanfang Hospital
    Taipei, Wenshan District 116, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04715776
Lead sponsor
Taipei Medical University WanFang Hospital
Collaborators
Hi-Q Marine Biotech International, Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Dec 10, 2018
Primary completion
Dec 16, 2019
Completion
Feb 28, 2021 (estimated)
Last update
Jan 20, 2021

Study contacts

Ming-Shun Wu
study director · Taipei Municipal Wanfang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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