Metabolic ProcessesNCT02381964
The Effects of Differing Cognitive Task Demands on Whole-body Energy Metabolism and Cerebral Blood-flow: Modulation by Multivitamins/Minerals and Coenzyme Q10
A study testing Supradyn® (1RDA+CoQ10) and Supradyn® (3RDA) in people with Metabolic Processes, run by Northumbria University at 1 site in United Kingdom.
Trial summary
When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen and glucose) via the blood. There is evidence to suggest that some nutritional supplements may increase blood circulation in the brain which can result in improved task performance. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Processes
- What is being tested?
- Supradyn® (1RDA+CoQ10) and Supradyn® (3RDA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Feb 2013
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females aged 25 to 50 years.
- Female subjects of childbearing potential must be using a medically acceptable form of birth control and have a negative pregnancy test at screening.
- Subjects agree to abstain throughout the trial from intake of MMP or supplements containing CoQ10.
- Body mass index (BMI) in the range of 18.50-34.99 kg/m2 (extremes included; including normal weight, overweight and class I obese subjects according to WHO BMI classification (WHO 2004)).
- Subjects are, in the opinion of the investigator willing to participate in all scheduled visits, to adhere to the treatment plan, and other trial procedures according to the protocol.
- Subjects accept to refrain from alcohol intake 24 hours and to fast 12 hours before the visits.
- Subjects do not have any condition which may interfere with the subject's ability to perform assessments (i.e. colour blindness) and successfully completes training
- Subjects provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial and understood and accepts these.
Who cannot join
- Physical parameters (including vital signs, e.g., blood pressure, pulse rate, respiratory rate and body temperature) deviating from normal and with clinical relevance.
- Acute infection at screening or randomization.
- A history of, neurological or psychiatric diseases excluding anxiety or depression.
- Current diagnosis of depression or anxiety.
- A history or current diagnosis of diseases, for which use of MMP might be contraindicated or utilisation of MMP might be affected (e.g., iron accumulation, iron utilisation disorders, hypercalcemia, hypercalciuria, impaired renal function, hypervitaminosis A, hypervitaminosis D).
- A history of significant head trauma.
Show all 16Show fewer
- Smoker (smoking within the last 3 months).
- Excessive use of caffeine (> 500 mg caffeine per day) from all dietary sources.
- History of migraines within the last five years.
- Current intake of pharmaceuticals (with exception of oral contraceptives, or other routine medications to treat benign conditions, such as antibiotics to treat acne).
- Habitual intake of MMP and dietary supplements within the last 4 weeks (defined as ≥3 consecutive days or ≥4 days in total per week).
- Current or history of drug or alcohol abuse in the opinion of the investigator.
- Current pregnancy or lactation.
- Participation in another clinical trial within 30 days prior to screening.
- Any condition which may interfere with the subject's ability to perform assessments (i.e. colour blindness).
- Any history of hypersensitivity to the investigational medicinal product or its active or inactive constituents or any food allergy or intolerance.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Pilot, Randomized, Placebo-controlled, Double-blind, 3-arm Parallel Groups Trial in Healthy Females to Assess Cerebral Haemodynamics and Energy Expenditure During Cognitive Performance After Supplementation With Two Different Multivitamin / Mineral Preparations.
When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen and glucose) via the blood. There is evidence to suggest that some nutritional supplements may increase blood circulation in the brain which can result in improved task performance. The purpose of the study is to evaluate the effects of a multivitamin/mineral preparation (containing a range of vitamins and minerals as contained in commonly consumed multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood flow and energy expenditure during cognitive task performance.
Read the detailed description
Vitamins, minerals and CoQ10, exert a number of physiological effects directly relevant to energy supply and metabolism. Therefore it is hypothesized that the nutritional interventions in this trial will facilitate brain metabolic substrate distribution and utilisation during demanding brain activities with a potential benefit on task performance. This pilot, double-blind, placebo controlled, 3-arm parallel groups trial will utilise two concomitant non-invasive techniques:
- Near Infrared Spectroscopy (NIRS) and
- Indirect Calorimetry (ICa). The NIRS will be utilised to measure the rate of delivery of metabolic substrates (via cerebral blood flow i.e. concentrations of total-haemoglobin) and oxygen extraction from the blood (concentration of deoxy-haemoglobin) in the frontal cortex of the brain during cognitive tasks.
The ICa calculated from exhaled gas analysis will be utilised to quantify the overall 'energy' costs of performance of tasks in terms of oxygen uptake, carbon dioxide production, energy expenditure, and substrate (fat and carbohydrate) metabolism.
Cognitive tasks of differing levels of difficulty will be utilised with the hypothesis that energy expenditure parameters and blood flow/oxygen extraction will increase with rising task demands, and that any treatment related effect will be more evident under conditions of increased neural activity. The effects on the above mentioned parameters of two multivitamin/multimineral preparations (MMP) will be compared to placebo subsequent to single dose administration (acute) and following daily administration over an eight week period (chronic). The nutritional interventions are expected to improve nutritional status and thereby facilitate energy supply and metabolism and to have positive impact on the study parameters. The effects of the nutritional interventions on nutritional status will be evaluated by measuring the plasma/serum concentrations of a selected subset of analytes. It is hypothesized that the nutritional status at baseline and after eight week supplementation period will have an impact on metabolic substrate conversion, oxygen utilisation, cerebral blood flow and cognitive performance.
- Conditions
- Metabolic Processes
- Being tested
- Supradyn® (1RDA+CoQ10), Supradyn® (3RDA), Placebo
- Keywords
- cerebral blood flow, cognitive function, vitamins, energy expenditure, NIRS, Indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supradyn® (1RDA+CoQ10)Dietary supplement
Supradyn® (3RDA)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched placebo Receives: Dietary Supplement: Placebo |
| 1RDA+CoQ10 | Experimental | Supradyn® (1RDA+CoQ10) containing vitamins and minerals at levels up to 100% of the 2008 European Union recommended dietary allowances (RDAs), plus 4.5 mg CoQ10 (1RDA+CoQ10). Receives: Dietary Supplement: Supradyn® (1RDA+CoQ10) |
| 3RDA | Experimental | Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA). Receives: Dietary Supplement: Supradyn® (3RDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Measured: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Measured: 1 hour post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Measured: 1 hour post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Measured: 1 hour post dose
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Measured: 56 days post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Measured: 56 days post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Measured: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Measured: 1 hour post dose
Total energy expenditure (Indirect calorimetry)
Measured: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Measured: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Measured: 56 days post dose
Total energy expenditure (Indirect calorimetry)
Measured: 56 days post dose
Secondary outcomes (32)
Serial 3 subtractions accuracy (Computerised cognitive task)
Measured: 1 hour post dose
Serial 3 subtractions accuracy (Computerised cognitive task)
Measured: 56 days post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Measured: 1 hour post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Measured: 56 days post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Measured: 1 hour post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Measured: 56 days post dose
3-back task accuracy (Computerised cognitive task)
Measured: 1 hour post dose
3-back task reaction time (Computerised cognitive task)
Measured: 1 hour post dose
3-back task accuracy (Computerised cognitive task)
Measured: 56 days post dose
3-back task reaction time (Computerised cognitive task)
Measured: 56 days post dose
Stroop task accuracy (Computerised cognitive task)
Measured: 1 hour post dose
Stroop task reaction time (Computerised cognitive task)
Measured: 1 hour post dose
Stroop task accuracy (Computerised cognitive task)
Measured: 56 days post dose
Stroop task reaction time (Computerised cognitive task)
Measured: 56 days post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subjective rating of task difficulty for Serial 7 substractions (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subjective rating of task difficulty for Serial 17 substractions (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subjective rating of task difficulty for Serial 7 subtractions (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subjective rating of task difficulty for Serial 17 subtractions (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Measured: 1 hour post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Measured: 56 days post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Measured: 1 hour post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Measured: 56 days post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Measured: 1 hour post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Measured: 56 days post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Measured: 1 hour post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Measured: 56 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic ProcessesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
- Investigators
- David O Kennedy, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381964
- Sponsor's protocol ID
- 9L4
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
Publications
Kennedy DO, Stevenson EJ, Jackson PA, Dunn S, Wishart K, Bieri G, Barella L, Carne A, Dodd FL, Robertson BC, Forster J, Haskell-Ramsay CF. Multivitamins and minerals modulate whole-body energy metabolism and cerebral blood-flow during cognitive task performance: a double-blind, randomised, placebo-controlled trial. Nutr Metab (Lond). 2016 Feb 11;13:11. doi: 10.1186/s12986-016-0071-4. eCollection 2016.
PubMed 26870152
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized, Placebo-controlled, Double-blind, 3-arm Parallel Groups Trial in Healthy Females to Assess Cerebral Haemodynamics and Energy Expenditure During Cognitive Performance After Supplementation With Two Different Multivitamin / Mineral Preparations.
- ClinicalTrials.gov ID
- NCT02381964
- Acronym / sponsor ID
- 9L4
- Conditions
- Metabolic Processes
- Keywords
- cerebral blood flow, cognitive function, vitamins, energy expenditure, NIRS, Indirect calorimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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.
When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen and glucose) via the blood. There is evidence to suggest that some nutritional supplements may increase blood circulation in the brain which can result in improved task performance. The purpose of the study is to evaluate the effects of a multivitamin/mineral preparation (containing a range of vitamins and minerals as contained in commonly consumed multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood flow and energy expenditure during cognitive task performance.
Detailed description
Vitamins, minerals and CoQ10, exert a number of physiological effects directly relevant to energy supply and metabolism. Therefore it is hypothesized that the nutritional interventions in this trial will facilitate brain metabolic substrate distribution and utilisation during demanding brain activities with a potential benefit on task performance. This pilot, double-blind, placebo controlled, 3-arm parallel groups trial will utilise two concomitant non-invasive techniques:
- Near Infrared Spectroscopy (NIRS) and
- Indirect Calorimetry (ICa). The NIRS will be utilised to measure the rate of delivery of metabolic substrates (via cerebral blood flow i.e. concentrations of total-haemoglobin) and oxygen extraction from the blood (concentration of deoxy-haemoglobin) in the frontal cortex of the brain during cognitive tasks.
The ICa calculated from exhaled gas analysis will be utilised to quantify the overall 'energy' costs of performance of tasks in terms of oxygen uptake, carbon dioxide production, energy expenditure, and substrate (fat and carbohydrate) metabolism.
Cognitive tasks of differing levels of difficulty will be utilised with the hypothesis that energy expenditure parameters and blood flow/oxygen extraction will increase with rising task demands, and that any treatment related effect will be more evident under conditions of increased neural activity. The effects on the above mentioned parameters of two multivitamin/multimineral preparations (MMP) will be compared to placebo subsequent to single dose administration (acute) and following daily administration over an eight week period (chronic). The nutritional interventions are expected to improve nutritional status and thereby facilitate energy supply and metabolism and to have positive impact on the study parameters. The effects of the nutritional interventions on nutritional status will be evaluated by measuring the plasma/serum concentrations of a selected subset of analytes. It is hypothesized that the nutritional status at baseline and after eight week supplementation period will have an impact on metabolic substrate conversion, oxygen utilisation, cerebral blood flow and cognitive performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched placebo |
| 1RDA+CoQ10 | Experimental | Dietary Supplement: Supradyn® (1RDA+CoQ10)Supradyn® (1RDA+CoQ10) containing vitamins and minerals at levels up to 100% of the 2008 European Union recommended dietary allowances (RDAs), plus 4.5 mg CoQ10 (1RDA+CoQ10). |
| 3RDA | Experimental | Dietary Supplement: Supradyn® (3RDA)Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy females aged 25 to 50 years.
- Female subjects of childbearing potential must be using a medically acceptable form of birth control and have a negative pregnancy test at screening.
- Subjects agree to abstain throughout the trial from intake of MMP or supplements containing CoQ10.
- Body mass index (BMI) in the range of 18.50-34.99 kg/m2 (extremes included; including normal weight, overweight and class I obese subjects according to WHO BMI classification (WHO 2004)).
- Subjects are, in the opinion of the investigator willing to participate in all scheduled visits, to adhere to the treatment plan, and other trial procedures according to the protocol.
Key exclusion criteria (16 listed)
- Physical parameters (including vital signs, e.g., blood pressure, pulse rate, respiratory rate and body temperature) deviating from normal and with clinical relevance.
- Acute infection at screening or randomization.
- A history of, neurological or psychiatric diseases excluding anxiety or depression.
- Current diagnosis of depression or anxiety.
- A history or current diagnosis of diseases, for which use of MMP might be contraindicated or utilisation of MMP might be affected (e.g., iron accumulation, iron utilisation disorders, hypercalcemia, hypercalciuria, impaired renal function, hypervitaminosis A, hypervitaminosis D).
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 |
|---|---|---|
| Supradyn® (1RDA+CoQ10) | Dietary supplement | 1RDA+CoQ10 |
| Supradyn® (3RDA) | Dietary supplement | 3RDA |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Time frame: 1 hour post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time frame: 1 hour post dose
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Concentration change in total hemoglobin (Near Infrared Spectroscopy)
Time frame: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Time frame: 1 hour post dose
Total energy expenditure (Indirect calorimetry)
Time frame: 1 hour post dose
Fat oxidation (Indirect calorimetry)
Time frame: 56 days post dose
Carbohydrate oxidation (Indirect calorimetry)
Time frame: 56 days post dose
Total energy expenditure (Indirect calorimetry)
Time frame: 56 days post dose
32 secondary outcomes
Serial 3 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 3 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 7 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Serial 17 subtractions accuracy (Computerised cognitive task)
Time frame: 56 days post dose
3-back task accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
3-back task reaction time (Computerised cognitive task)
Time frame: 1 hour post dose
3-back task accuracy (Computerised cognitive task)
Time frame: 56 days post dose
3-back task reaction time (Computerised cognitive task)
Time frame: 56 days post dose
Stroop task accuracy (Computerised cognitive task)
Time frame: 1 hour post dose
Stroop task reaction time (Computerised cognitive task)
Time frame: 1 hour post dose
Stroop task accuracy (Computerised cognitive task)
Time frame: 56 days post dose
Stroop task reaction time (Computerised cognitive task)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 7 substractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 17 substractions (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 7 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for Serial 17 subtractions (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time frame: 1 hour post dose
Subject ratings of energy levels (Computerised Visual Analogue Scale)
Time frame: 56 days post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of calmness (Computerised Bond-Lader mood scales)
Time frame: 56 days post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of contentedness (Computerised Bond-Lader mood scales)
Time frame: 56 days post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time frame: 1 hour post dose
Subject ratings of alertness (Computerised Bond-Lader mood scales)
Time frame: 56 days 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 30 Mar 2018.
- Derived from this study: PubMed 26870152Kennedy DO, Stevenson EJ, Jackson PA, Dunn S, Wishart K, Bieri G, Barella L, Carne A, Dodd FL, Robertson BC, Forster J, Haskell-Ramsay CF. Multivitamins and minerals modulate whole-body energy metabolism and cerebral blood-flow during cognitive task performance: a double-blind, randomised, placebo-controlled trial. Nutr Metab (Lond). 2016 Feb 11;13:11. doi: 10.1186/s12986-016-0071-4. eCollection 2016.
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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.
David O Kennedy, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supradyn® (1RDA+CoQ10) and Supradyn® (3RDA) in people with Metabolic Processes, run by Northumbria University at 1 site in United Kingdom.
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 8 inclusion and 16 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy) (time frame: 1 hour post dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381964, which also lists 1 linked publication.
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 30 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.