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

Study Overview
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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.

Official Title
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Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract

Conditions
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Cognitive Change

Intervention / Treatment
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* Dietary Supplement: 500mg brown seaweed powder
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 500mg brown seaweed powder<br>2 x 250mg capsules InSea2® (brown seaweed powder) | Dietary Supplement: 500mg brown seaweed powder<br> <br> * Other names: InSea2®;|
| Placebo Comparator: Placebo<br>2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®) | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-prandial cognition, brown seaweed