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

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Dietary Supplement: 500mg brown seaweed powder; Dietary Supplement: Placebo

• Registration Number: NCT03328923
• Lead Sponsor: Northumbria University

Brief Summary

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

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 Timeline

• Study Start: 2016-06-23
• Primary Completion: 2016-07-28
• Study Completion: 2016-07-28
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-27
• Status Verified: 2017-11
• Study First Posted: 2017-11-01
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500mg brown seaweed powder	500mg brown seaweed powder	2 x 250mg capsules InSea2® (brown seaweed powder)
Placebo	Placebo	2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Subjective state	Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose	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)