Effects of Seaweed Extract on Mental Performance Following a High-carbohydrate Meal

Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract

The current study will explore the impact of seaweed extract on cognitive function following a high-carbohydrate meal at a number of time-points post-consumption.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: 500mg brown seaweed powder

Detailed Description

The current randomised, placebo-controlled, double-blind, parallel groups study will examine the impact of a brown seaweed extract (InSea2) on cognitive function post-prandially in 60 healthy non-elderly adults who self-report post-meal drowsiness. Computerised measures of episodic memory, attention and subjective state will be completed at baseline and for 3 hours following lunch with either seaweed or placebo consumed 30 minutes prior to a carbohydrate-rich meal.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Report post-meal drowsiness

Exclusion Criteria:

Below 18 or above 65 years old at the time of giving consent

• Do not report post-meal drowsiness
• Any pre-existing medical condition/illness
• History of/current head trauma
• History of intestinal tract surgery
• History of/current diagnosis of drug/alcohol abuse
• Currently taking prescription medications (excluding the contraceptive pill)
• Habitual use of dietary/herbal supplements
• Learning difficulties, ADHD (attention deficit hyperactivity disorder), dyslexia
• Frequent migraines that require medication more than once/month.
• Visual impairment that cannot be corrected with glasses or contact lenses
• Smoking
• Excessive use of caffeine (>500mg per day) from all dietary sources
• Not a native English speaker
• Food intolerances/sensitivities, including seafood/fish allergy
• Pregnancy, seeking to become pregnant, or current lactation
• BMI <18.5 or >30 kg/m2
• Any health condition that would prevent fulfilment of the study requirements
• Inability to complete all of the study assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500mg brown seaweed powder; 2 x 250mg capsules InSea2® (brown seaweed powder)	Dietary supplement: 500mg brown seaweed powder; Other Names: InSea2®
Placebo Comparator: Placebo; 2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®)	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	Immediate word recall, simple reaction time, digit vigilance and choice reaction time measured via the Computerised Mental Performance Assessment System (COMPASS, Northumbria University)	Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective state	Concentration, mental stamina, physical stamina, mental tiredness, physical tiredness, hunger, thirst and fullness visual analogue scales measured via the Computerised Mental Performance Assessment System (COMPASS, Northumbria University)	Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: innoVactiv Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2016
• Primary Completion (Actual): July 28, 2016
• Study Completion (Actual): July 28, 2016

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: brown seaweed; post-prandial cognition
• Other Study ID Numbers: 46BK1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No