search
Back to results

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

Primary Purpose

Type II Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Brown seaweed
placebo
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type II Diabetes focused on measuring Diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Pre-DM patients with placebo

Pre-DM patients with supplement

DM patients with placebo

DM patients with supplement

Arm Description

Pre-Diabetes patients uptake placebo as dietary supplement

Pre-Diabetes patients uptake Brown seaweed as dietary supplement

Diabetes patients uptake placebo as dietary supplement.

Diabetes patients uptake Brown seaweed as dietary supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 4, 2018
Last Updated
January 18, 2021
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Hi-Q Marine Biotech International, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04715776
Brief Title
Supplementation of Brown Seaweed on Insulin Resistance of NAFLD Patients With Pre- or Type 2-Diabetes
Official Title
Supplementation of Brown Seaweed on Insulin Resistance of NAFLD Patients With Pre- or Type 2-Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Hi-Q Marine Biotech International, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-DM patients with placebo
Arm Type
Placebo Comparator
Arm Description
Pre-Diabetes patients uptake placebo as dietary supplement
Arm Title
Pre-DM patients with supplement
Arm Type
Experimental
Arm Description
Pre-Diabetes patients uptake Brown seaweed as dietary supplement
Arm Title
DM patients with placebo
Arm Type
Placebo Comparator
Arm Description
Diabetes patients uptake placebo as dietary supplement.
Arm Title
DM patients with supplement
Arm Type
Experimental
Arm Description
Diabetes patients uptake Brown seaweed as dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Brown seaweed
Intervention Description
Uptake of 1650 mg brown seaweed product twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Uptake of 1650 mg placebo twice daily
Primary Outcome Measure Information:
Title
From baseline to 3 months after using dietary supplements (compare yourself with yourself), follow up for a total of 12 months
Description
The change of HbA1c
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu
Organizational Affiliation
Taipei Municipal Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wanfang Hospital
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs