Effect of Sea Weed (Ecklonia Cava Extract) on Blood Glucose and Insulin Level on Pre-diabetic Patients

Summary

Introduction:

The inhibition of α-amylase and α-glucosidase enzymes is suggested strategy for glycemic control particularly in people with prediabetes and diabetes. Polyphenola-rich brown seaweed extracts, have been proposed to have similar inhibition effect on α-amylases and α-glucosidases, thus improving diabetic related response. This proposal aims to investigate the effect of seaweed extract called E. cava on postprandial blood glucose (PPBG) and postprandial plasma insulin level (PPIL). Likewise, the study will examine any intolerance symptoms associated with the consumption of the studied seaweed extract.

Objectives:

Investigate the effectiveness of seaweed (E. cava) in reducing postprandial blood glucose and plasma insulin level in pre-diabetic patients, compared to placebo.

Investigate the safeness and potential adverse effect of applying sea weed (E. cava) as a therapeutic diet composition on patient with pre-diabetes, compared to placebo.

Methods:

Double-blind, Randomized-controlled trial that will be conducted from 1st March 2021 to 20th July 2021 in Saudi Arabia. Participants will be eligible to participate in this study if they are diagnosed in their medical history as pre-diabetic patient through their medical records aged between 18 and 65 years with fasting plasma glucose (FPG) between 100 and 125 mg dL-1 as a set criterion by American Diabetic Association (ADA), and blood pressure within the normal range (systolic blood pressure ≤ 140 mmHg, diastolic blood pressure ≤ 90 mmHg set by World Health Organization (WHO) having no other health complications. Participants will be excluded if they are smoker, pregnant or lactation or having liver, thyroid, significant gastrointestinal disorders, taking any treatment with either insulin or anti-diabetic drugs or any other natural health products known to impact blood sugar. The number of individuals is required to detect differences of 38 units in BG and 2500-unit in plasma insulin (incremental under the curve (iAUC)) at 0.05 significance level with 80% power of the study. Study supplements (intervention and placebo) will be encapsulated in identical capsules and will be labelled with the letter A and B to conceal which supplement is given to participants each testing occasion. computer-generating randomization, data collection and analysis will be double-blinded.

The intervention product used in this study is a dietary supplement capsules called "Seanol" that contain 13% pholoratannic polyphenol per capsule as stated by the manufacture company (seanol inside, 4215 95th St SW Lakewood, WA 98499 USA). Prior carbohydrates consumption, 2 capsule (1000 mg of E. cava), that contain 150 mg of pholorotanic polyphenol containing polyphenol will be administered at a single occasion for postprandial testing. This dose was selected to be similar to previous studies that shows no harm or sever adverse effect on participants (12, 14). placebo will be Similar in composition to the intervention.

Plasma glucose concentration will be determined immediately by blood finger-prick sample following standard procedure using HemoCue Glucose 201 RT System (Radiometer Pacific Pty Ltd, Mount Waverley, VIC, Australia). Whereas, plasma insulin will be measured at the laboratory department at KKUH using enzyme-linked immunosorbent assay (ELISA) Statistics Mann-Whitney test will be used to determine differences for symptoms of intolerance between groups. Incremental area under the curve (iAUC), time to peak and peak blood concentration assessment will be used to assess postprandial responses of for plasma glucose and insulin level. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 20.

Conditions

• PreDiabetes

Interventions

DIETARY_SUPPLEMENT

brown seaweed (ecklonia cava)

The intervention product used in this study is a dietary supplement called "Seanol" that contain 13% pholoratannic polyphenol per capsule as stated by the manufacture company (Seanol inside, 4215 95th St SW Lakewood, WA 98499 USA). Other ingredients are dextrin, magnesium stearate and silica (in neglected percentage). The intervention supplement is encapsulated in vegetable cellulose that contains 500 Ecklonia cava extract (Seanol). The placebo will be dextrin (BETA CYCLODEXTRIN, NF) ordered from a pharmaceutical company "MEDISCA" (https://www.medisca.co.uk/). Dextrin was selected to account for the similar complex carbohydrate content of the intervention supplement. Placebo will be encapsulated in vegetable cellulose capsules that is identical in size and coulure to the intervention capsules. The empty capsules will be ordered from MEDISCA and will be encapsulated in by SPIMACO ADDWAIEH (SFDA registered pharmaceutical company) (http://www.spimaco.com.sa/).

Sponsors & Collaborators

• Dr. Khalid ALdybayan

  collaborator UNKNOWN

• Ms. Haneen Molla

  collaborator UNKNOWN

• Dr. Abdullah Alquwaihes

  collaborator UNKNOWN

• King Saud University

  lead OTHER

Principal Investigators

• Malak Almutairi, Masters · PI

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2021-12-20

Completion

2021-12-30

FDA Drug

Yes

Countries

• Saudi Arabia

Study Locations