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Completed

NCT Number: NCT03328923

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500mg brown seaweed powder

Dietary Supplement

Other names: InSea2®

Placebo

Dietary Supplement

Primary outcomes

  1. Cognitive performance

    Time frame: 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 outcomes

  1. Subjective state

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • innoVactiv Inc.

Registry information

Official study title

Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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