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

Not Applicable

• Conditions: Type II Diabetes
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Brown seaweed

• Registration Number: NCT04715776
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

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 Timeline

• Study First Submitted: 2018-09-04
• Study Start: 2018-12-10
• Primary Completion: 2019-12-16
• Status Verified: 2020-08
• Study First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-DM patients with placebo	placebo	Pre-Diabetes patients uptake placebo as dietary supplement
Pre-DM patients with supplement	Brown seaweed	Pre-Diabetes patients uptake Brown seaweed as dietary supplement
DM patients with placebo	placebo	Diabetes patients uptake placebo as dietary supplement.
DM patients with supplement	Brown seaweed	Diabetes patients uptake Brown seaweed as dietary supplement

Primary Outcome Measures

Name	Time	Method
From baseline to 3 months after using dietary supplements (compare yourself with yourself), follow up for a total of 12 months	12 months	The change of HbA1c

Trial Locations

Locations (1)

Wanfang Hospital; 🇨🇳 Taipei, Wenshan District, Taiwan