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

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.

Study Overview

• Status: Unknown
• Conditions: Type II Diabetes
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Brown seaweed

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Wenshan District
    • Taipei, Wenshan District, Taiwan, 116
      • Wanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Pre-DM patients with placebo; Pre-Diabetes patients uptake placebo as dietary supplement	Dietary supplement: placebo; Uptake of 1650 mg placebo twice daily
EXPERIMENTAL: Pre-DM patients with supplement; Pre-Diabetes patients uptake Brown seaweed as dietary supplement	Dietary supplement: Brown seaweed; Uptake of 1650 mg brown seaweed product twice daily
PLACEBO_COMPARATOR: DM patients with placebo; Diabetes patients uptake placebo as dietary supplement.	Dietary supplement: placebo; Uptake of 1650 mg placebo twice daily
EXPERIMENTAL: DM patients with supplement; Diabetes patients uptake Brown seaweed as dietary supplement	Dietary supplement: Brown seaweed; Uptake of 1650 mg brown seaweed product twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Hi-Q Marine Biotech International, Ltd.
• Investigators: Study Director: Ming-Shun Wu, Taipei Municipal Wanfang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ACTUAL): December 16, 2019
• Study Completion (ANTICIPATED): February 28, 2021

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: N201805009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No