Clinical trial NCT04715776: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type II Diabetes
Keywords: Diabetes
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Hi-Q Marine Biotech International, Ltd.
First posted: 2021-01-20
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: From baseline to 3 months after using dietary supplements (compare yourself with yourself), follow up for a total of 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wanfang Hospital
state: Wenshan District
Study officials:
affiliation: Taipei Municipal Wanfang Hospital
name: Ming-Shun Wu
role: STUDY_DIRECTOR
References: