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

NCT03328923 | Completed

• 1 other identifier: 46BK1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Change

Keywords

post-prandial cognition; brown seaweed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective state

  Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose

Study Arms (2)

500mg brown seaweed powder

EXPERIMENTAL

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

Dietary Supplement: 500mg brown seaweed powder

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

500mg brown seaweed powder DIETARY_SUPPLEMENT

Also known as: InSea2®

500mg brown seaweed powder

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Report post-meal drowsiness

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• innoVactiv Inc.: collaborator

Study Officials

• Crystal Haskell-Ramsay, Dr

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will receive either 500mg brown seaweed powder (InSea2) or placebo

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 1, 2017
• Study Start: June 23, 2016
• Primary Completion: July 28, 2016
• Study Completion: July 28, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share