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

NCT ID: NCT03328923

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-23

Study Completion Date

2016-07-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Change

Keywords

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post-prandial cognition brown seaweed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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500mg brown seaweed powder

2 x 250mg capsules InSea2® (brown seaweed powder)

Group Type EXPERIMENTAL

500mg brown seaweed powder

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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500mg brown seaweed powder

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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InSea2®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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innoVactiv Inc.

INDUSTRY

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Crystal Haskell-Ramsay

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Crystal Haskell-Ramsay, Dr

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Other Identifiers

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46BK1

Identifier Type: -

Identifier Source: org_study_id