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

NCT04864860 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: SW2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pre-diabetes; brown seaweed; eklonia cava; hyperglycemia; postprandial blood glucose; postprandial insulin level

Outcome Measures

Primary Outcomes (2)

• postprandial blood glucose concentration

  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).

  postprandial (30 minutes, 60 minutes, 90 minutes, 120 minutes)

• postprandial blood insulin concentration

  plasma insulin will be measured at the laboratory department at KKUH using enzyme-linked immunosorbent assay (ELISA).

  postprandial (30 minutes, 60 minutes, 90 minutes, 120 minutes)

Secondary Outcomes (1)

• side effect of ecklonia cava

  24 hour later of collecting last blood samples at 120 minute

Study Arms (2)

intervention arm

EXPERIMENTAL

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). This dose was selected to be similar to previous studies that shows no harm or sever adverse effect on participants (12, 14).

Dietary Supplement: brown seaweed (ecklonia cava)

placebo arm

PLACEBO COMPARATOR

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/).

Dietary Supplement: brown seaweed (ecklonia cava)

Interventions

brown seaweed (ecklonia cava) DIETARY_SUPPLEMENT

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/).

Also known as: Placebo (dextrin)

intervention arm; placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 and 65 years.
• diagnosed in their medical history as pre-diabetic patient with fasting plasma glucose (FPG) between 100 and 125 mg dL-1.
• blood pressure within the normal range (systolic blood pressure ≤ 140 mmHg, diastolic blood pressure ≤ 90 mmHg).
• having no other health complications.

You may not qualify if:

• taking any treatment with either insulin or anti-diabetic drugs.
• taking any other natural health products known to impact blood sugar, or polyphenol absorption (e.g. fish oil).
• having liver, thyroid, or significant gastrointestinal disorders.
• pregnant or lactation
• currently Smoker.

Sponsors & Collaborators

• King Saud University: lead
• Dr. Khalid ALdybayan: collaborator
• Ms. Haneen Molla: collaborator
• Dr. Abdullah Alquwaihes: collaborator

Study Sites (1)

clinical Trial Unit

Riyadh, 11362, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Hyperglycemia

Interventions

Dextrins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Malak Almutairi, Masters

  PI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malak G Almutairi, Masters

CONTACT

+966544479135; malak.rog@gmail.com

Dr. Khalid Aldubayan Molla, pHD

CONTACT

+966506445631; kaldubayan@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The identity of the supplement Study randomization will be administered by encoding participants with numbers and supplements (intervention \& placebo) with letters (A, B). 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.will only be known to an investigator who will not be involved in data collection and analysis. Participants and investigators who will conduct recruitment, data collection and data analysis will be blinded to which supplement is consumed each occasion until data analysis completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Computer-generating randomization will be used to randomly select participants from eligible subjects. Then, participants will be assigned randomly into one of the two groups (intervention vs placebo).

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: March 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 30, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)