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

Cognitive Change Clinical Trial

Official title:

Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328923
• Other study ID #: 46BK1
• Status: Completed
• Phase: N/A
• First received: October 23, 2017
• Last updated: November 2, 2017
• Start date: June 23, 2016
• Est. completion date: July 28, 2016

Study information

• Verified date: November 2017
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Dietary Supplement:
• 500mg brown seaweed powder

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	innoVactiv Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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