Cognitive ChangeNCT03328923
Effects of Seaweed Extract on Mental Performance Following a High-carbohydrate Meal
A study testing 500mg brown seaweed powder in people with Cognitive Change, run by Northumbria University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- 500mg brown seaweed powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2016to 28 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Report post-meal drowsiness
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
Official title: Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract
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.
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- 500mg brown seaweed powder, Placebo
- Keywords
- post-prandial cognition, brown seaweed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg brown seaweed powderDietary supplement
Also called InSea2®
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 500mg brown seaweed powder | Experimental | 2 x 250mg capsules InSea2® (brown seaweed powder) Receives: Dietary Supplement: 500mg brown seaweed powder |
| Placebo | Placebo comparator | 2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Secondary outcomes (1)
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)
Measured: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start23 Jun 2016
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- innoVactiv Inc.
- Responsible party
- Principal investigator, Crystal Haskell-Ramsay, Northumbria University
- Investigators
- Crystal Haskell-Ramsay, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328923
- Sponsor's protocol ID
- 46BK1
- Status last verified
- Nov 2017
- First submitted
- 23 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract
- ClinicalTrials.gov ID
- NCT03328923
- Acronym / sponsor ID
- 46BK1
- Conditions
- Cognitive Change
- Keywords
- post-prandial cognition, brown seaweed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- innoVactiv Inc.
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
| Arm | Type | Receives |
|---|---|---|
| 500mg brown seaweed powder | Experimental | Dietary Supplement: 500mg brown seaweed powder2 x 250mg capsules InSea2® (brown seaweed powder) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Report post-meal drowsiness
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500mg brown seaweed powderAlso: InSea2® | Dietary supplement | 500mg brown seaweed powder |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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)
1 secondary outcome
Subjective state
Time frame: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Haskell-Ramsay, Dr principal investigator
Northumbria University
Questions about this trial
What is this clinical trial studying?
A study testing 500mg brown seaweed powder in people with Cognitive Change, run by Northumbria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance (time frame: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.