Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched 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). |
|
| 3RDA | Experimental | Supradyn® (3RDA) containing vitamins and minerals at levels up to 300% of the 1990 European Union RDAs (3RDA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supradyn® (1RDA+CoQ10) | Dietary Supplement |
| ||
| Supradyn® (3RDA) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy) | 1 hour post dose | |
| Fat oxidation (Indirect calorimetry) | 1 hour post dose | |
| Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy) | 1 hour post dose | |
| Concentration change in total hemoglobin (Near Infrared Spectroscopy) | 1 hour post dose | |
| Concentration change in oxygenated hemoglobin (Near Infrared Spectroscopy) | 56 days post dose | |
| Concentration change in deoxygenated hemoglobin (Near Infrared Spectroscopy) | 56 days post dose | |
| Concentration change in total hemoglobin (Near Infrared Spectroscopy) | 56 days post dose | |
| Carbohydrate oxidation (Indirect calorimetry) | 1 hour post dose | |
| Total energy expenditure (Indirect calorimetry) | 1 hour post dose | |
| Fat oxidation (Indirect calorimetry) | 56 days post dose | |
| Carbohydrate oxidation (Indirect calorimetry) |
| Measure | Description | Time Frame |
|---|---|---|
| Serial 3 subtractions accuracy (Computerised cognitive task) | 1 hour post dose | |
| Serial 3 subtractions accuracy (Computerised cognitive task) | 56 days post dose | |
Not provided
Inclusion Criteria:
Healthy females aged 25 to 50 years.
Exclusion Criteria:
Physical parameters (including vital signs, e.g., blood pressure, pulse rate, respiratory rate and body temperature) deviating from normal and with clinical relevance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David O Kennedy, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain performance and nutrition research centre, Northumbria university | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26870152 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement |
|
| 56 days post dose |
| Total energy expenditure (Indirect calorimetry) | 56 days post dose |
| Serial 7 subtractions accuracy (Computerised cognitive task) |
| 1 hour post dose |
| Serial 7 subtractions accuracy (Computerised cognitive task) | 56 days post dose |
| Serial 17 subtractions accuracy (Computerised cognitive task) | 1 hour post dose |
| Serial 17 subtractions accuracy (Computerised cognitive task) | 56 days post dose |
| 3-back task accuracy (Computerised cognitive task) | 1 hour post dose |
| 3-back task reaction time (Computerised cognitive task) | 1 hour post dose |
| 3-back task accuracy (Computerised cognitive task) | 56 days post dose |
| 3-back task reaction time (Computerised cognitive task) | 56 days post dose |
| Stroop task accuracy (Computerised cognitive task) | 1 hour post dose |
| Stroop task reaction time (Computerised cognitive task) | 1 hour post dose |
| Stroop task accuracy (Computerised cognitive task) | 56 days post dose |
| Stroop task reaction time (Computerised cognitive task) | 56 days post dose |
| Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subjective rating of task difficulty for Serial 7 substractions (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subjective rating of task difficulty for Serial 17 substractions (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subjective rating of task difficulty for Serial 3 subtractions (Computerised Visual Analogue Scale) | 56 days post dose |
| Subjective rating of task difficulty for Serial 7 subtractions (Computerised Visual Analogue Scale) | 56 days post dose |
| Subjective rating of task difficulty for Serial 17 subtractions (Computerised Visual Analogue Scale) | 56 days post dose |
| Subjective rating of task difficulty for 3 back task (Computerised Visual Analogue Scale) | 56 days post dose |
| Subjective rating of task difficulty for stroop task (Computerised Visual Analogue Scale) | 56 days post dose |
| Subject ratings of energy levels (Computerised Visual Analogue Scale) | 1 hour post dose |
| Subject ratings of energy levels (Computerised Visual Analogue Scale) | 56 days post dose |
| Subject ratings of calmness (Computerised Bond-Lader mood scales) | 1 hour post dose |
| Subject ratings of calmness (Computerised Bond-Lader mood scales) | 56 days post dose |
| Subject ratings of contentedness (Computerised Bond-Lader mood scales) | 1 hour post dose |
| Subject ratings of contentedness (Computerised Bond-Lader mood scales) | 56 days post dose |
| Subject ratings of alertness (Computerised Bond-Lader mood scales) | 1 hour post dose |
| Subject ratings of alertness (Computerised Bond-Lader mood scales) | 56 days post dose |
| ID | Term |
|---|---|
| C086404 | Supradyn |
Not provided
Not provided
Not provided