AgingPhase 2MOBILENCT03228550
Omega-3 Fatty Acids and Exercise on Mobility and Cognition in Older Women
A Phase 2 study testing Efamol Active 50+ and Aerobic exercise in people with Aging and Cognitive Decline, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
The study will provide insight into how lifestyle-related interventions, specifically nutrition and exercise can impact the health of older women. The study uses a unique combination of interventions and encapsulates overall health outcomes by measuring both mobility and cognitive function. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline
- What is being tested?
- Efamol Active 50+ and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2017to 31 Dec 2018
- Phase
- Phase 2
- 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to walk 50 meters unassisted
- Non-frail or pre-frail according to Fried frailty phenotype
Who cannot join
- Vestibular impairments
- Diagnosed neurological disorder
- Mini mental state examination score of ≤24
- History of lower limb surgery
- Seafood allergy
- Regular consumption of multivitamin/fish oil supplements within six months prior to baseline measurements
- Previously received advice from a health care professional to not take part in strenuous exercise.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bournemouth University
Bournemouth, Dorset, BH1 3LT
About this study
Official title: Investigating the Effects of Omega-3 Fatty Acid Multinutrient Supplement and Exercise on Mobility and Cognition in Older Women
The study will provide insight into how lifestyle-related interventions, specifically nutrition and exercise can impact the health of older women. The study uses a unique combination of interventions and encapsulates overall health outcomes by measuring both mobility and cognitive function.
The study examines the effects of a combined omega-3 polyunsaturated fatty acid (PUFA) and multi-nutrient supplement on measures of mobility and cognition in women aged 60 years and above. Volunteers for the study will be randomly assigned to one of four groups which are as follows:
Read more
- Omega-3 PUFA multi-nutrient supplement and aerobic exercise
- Omega-3 PUFA multi-nutrient supplement and no exercise
- Placebo supplement and aerobic exercise
- Placebo supplement and no exercise
Volunteers undertake the dietary supplementation for a period of 24 weeks. The active dietary supplement contains a daily dosage of 1 g docosahexaenoic acid, 160 mg eicosapentaenoic acid, 240 mg Ginkgo biloba, 60 mg phosphatidylserine, 20 mg d-α tocopherol, 1 mg folic acid, and 20 µg vitamin B12. The placebo supplement contains an iso-calorific oil blend that is typical of the current UK diet. The aerobic exercise consists of two classes per week the final 12 weeks of the study on stationary spinning exercise bikes.
Volunteers attend testing at the beginning and after 24 weeks. Verbal memory, spatial working memory, executive function and processing speed are assessed via a battery of cognitive tests. Mobility testing comprises three walking tests, some under single and dual task paradigms, as well as the five times sit to stand test, a measure of dynamic balance and functional mobility. Volunteers also provide two blood samples, one for fatty acids analysis and the other serum homocysteine levels. Participants also complete health-related quality of life questionnaire, the short form 36 (SF36) questionnaire, food diary and food frequency questionnaire.
Read the detailed description
Design and Setting:
The study is a randomized semi-blinded, placebo-controlled trial in females aged 60 years and over. The study examines the effects of a high docosahexaenoic acid omega-3 PUFA multi-nutrient dietary supplement and aerobic exercise, both on their own and in combination, on outcomes related to mobility and cognition. All measurements and data collection, as well as the aerobic exercise, take place at the same study site (Bournemouth University, United Kingdom), with participants instructed to consume the dietary supplement at home.
Blinding Randomization and Allocation:
The dietary supplements are packed in identical containers and coded by the Principal Investigator, who has no involvement in the data collection. Omega-3 PUFA capsules have a distinct odor, therefore a small amount of fish oil is added to the placebo capsules to help maintain blinding. A stratified block randomization design is followed with stratification based on frailty classification of non-frail or pre-frail, followed by permuted block randomization. Randomization is achieved by creating a computer-generated list of numbers consisting of four blocks for each stratum referred to without specification of the intervention group (e.g., A, B, C, and D). The list is generated and stored by the Principal Investigator. Due to the nature of the exercise intervention participants are only be blinded to the dietary intervention; however, the experimenters are blinded to the exercise group allocations.
Participants:
Participants are recruited through local newspaper advertisements and public engagements in Bournemouth, U.K. The public advertisements include a brief study description as well as the contact details for the research team. Those who are interested receive a participant information document including the design, procedure, benefits, and risks of the study. Before any data is collected, all participants provide signed written informed consent forms.
All participants are screened to assess frailty status, according to the Fried et al. (2001) criteria. The criteria include low muscle strength, self-reported exhaustion, slowed gait speed, low levels of physical activity, and unintentional weight loss. A score of zero out of the five indicates non-frail, one or two pre-frail, and three or above frail.
The Mini Mental State Examination (MMSE) is performed to exclude participants with cognitive impairment, as this has the potential to go undiagnosed. The test is performed according to British Psychology Society guidelines, and is not used for diagnostic purposes and individual results are not be disclosed to any participant. Participants who score ≤24 are excluded from the study.
Demographic Information:
Information on the age, height, weight, verbal intelligence and medication use is collected from each participant. Information on medications is self-reported, with both type and number of medications recorded. The national adult reading test (NART) is used to assess verbal intelligence. The test requires participants to read aloud 50 pre-prepared words, with scores being calculated based on the number of correct pronunciations. Minor variations from the pronunciations are not penalized as the aim of the test is to assess familiarity with the words rather than exact pronunciation.
Sample Size:
Sample size was determined based on the primary outcome of habitual gait speed. The sample size calculation was based on a difference of 0.08 m/sec with a power of 0.8 and α of 0.05 (two-tailed), based on previous research (Strike et al. 2016). A minimum sample size of 25 participants per group is required to detect an effect size d of 0.8 between experimental groups and the control. An overall recruitment target of 120 participants, 30 per group has been set to allow for drop-outs.
Analysis will be carried out on the basis of groups as randomly assigned. This intention-to-treat analysis will include participants who decide to discontinue treatment, but take part in assessment at 24 weeks. Data analysis will be performed at the conclusion of the intervention and include data collected at baseline and 24 weeks. Data will be tested for normal distribution using Shapiro-Wilk test and Q-Q-plots. Associations between baseline levels of serum homocysteine, whole-blood DHA levels and cognitive and mobility outcomes will be made, as well as changes in DHA and measures of mobility and cognition at the end of the intervention. The treatment effects of the two interventions over time (from pre- and post-measurements) will be analyzed by 2 X 2 ANOVA, with demographic and health information, such as age and NART score, and changes in serum homocysteine and changes in blood fatty acids examined as covariates. This analysis will be performed on all primary and secondary outcomes. Effect size will also be calculated. In all analyses P<0.05 will be considered significant.
- Conditions
- Aging, Cognitive Decline
- Being tested
- Efamol Active 50+, Aerobic exercise, Placebo multinutrient
- Keywords
- omega-3 fatty acid, B vitamins, vitamin E, Phosphatidylserine, Gingko biloba, Gait, Aerobic Exercise, Memory, Cognitive function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efamol Active 50+Dietary supplement
1000 mg docosahexaenoic acid, 160 mg eicosapentaenoic acid, 20 µg B12, 1 mg folic acid, 124 mg phosphatidylserine, 240 mg ginkgo biloba standardized leaf extract and 20 mg vitamin E
Aerobic exerciseBehavioural
Static exercise cycle
Placebo multinutrientDietary supplement
Placebo multinutrient supplement
| Study group | Role | What they receive |
|---|---|---|
| Efamol Active 50+ and exercise | Experimental | Efamol Active 50+ Multinutrient supplement and aerobic exercise Receives: Dietary Supplement: Efamol Active 50+; Behavioral: Aerobic exercise |
| Efamol Active 50+ and non-exercise | Experimental | Efamol Active 50+ Multinutrient supplement and non-aerobic exercise Receives: Dietary Supplement: Efamol Active 50+ |
| Placebo and exercise | Experimental | Placebo supplement and aerobic exercise Receives: Behavioral: Aerobic exercise; Dietary Supplement: Placebo multinutrient |
| Placebo and non-exercise | Experimental | Placebo supplement and non- exercise Receives: Dietary Supplement: Placebo multinutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in habitual gait speed
Habitual gait speed will be measured using inertial measurement sensors and will be expressed in m/s. Participants will be asked to walk at their normal habitual pace over 13 m. Acceleration and deceleration periods will automatically be excluded from analysis and the measure will be repeated five times with the mean value calculated.
Measured: Baseline and 24 weeks post intervention
Secondary outcomes (16)
Change in executive function
Participants draw lines between targets, as rapidly as possible, in a seven by seven grid. There are four different conditions for the task: a numbers condition where targets go from one to forty nine (numbers), a letters condition were the targets go from A to Z followed by letters A to W with an asterisk to signify the letters as the second instance (letters), A condition where participants will alternate between numbers and letters swapping between numbers one to twenty five and letters A to X (numbers-letters) and finally a condition alternating between letters and numbers alternating between letters A to Y and numbers one and twenty four (letters-numbers). Participants will be given 20 s to make as many connections as possible on each task condition. Total number of correct connections will be recorded.
Measured: Baseline and 24 weeks post intervention
Change in verbal memory
The Rey's auditory verbal learning test will be used to assess verbal memory. Participants will be read a list of fifteen common words five times. Immediately after each reading, they will recall as many words as possible. Next an interference list will be read containing fifteen different words, after which participants will be asked to recall the original list. In the last trial participants will be asked to recall the original list after a twenty minute delay.
Measured: Baseline and 24 weeks post intervention
Change in processing speed
A variation on the Stroop Test performed on a laptop using Open Sesame software will be used to assess processing speed. During this task a fixation point appears on screen for 500 milliseconds followed by the presentation of the names of one of four colors blue, red, green or white. These words will be presented in four different colors again this could be either blue, red, green or white. Participants will be instructed to identify, as quickly as possible, the color of the text rather than the word displayed on screen and press a designated key on the keyboard for each of the colors. The test is comprised of 144 trials with half of trials having the text and color match and half being a non-match. Processing speed is automatically calculated by the software and is defined as the difference between the mean time taken to respond to the match and non-math trials.
Measured: Baseline and 24 weeks post intervention
Change in spatial working memory
This task takes place on a laptop using Open Sesame software. Participants are asked to recall the spatial locations of three dots that appear in random locations on screen. The task consists on 10 practice trials followed by 60 recorded trials, with percentage of correct answers being recorded.
Measured: Baseline and 24 weeks post intervention
Change in fast walking speed
Fast walking speed will be measured using inertial measurement sensors and results will be expressed in m/s. Participants will be asked to walk as fast as possible over 13 m. Acceleration and deceleration periods will automatically be excluded from analysis and the measure will be repeated five times with the highest value being recorded.
Measured: Baseline and 24 weeks post intervention
Change in dual task walking speed
Dual task walking speed will be measured using inertial measurement sensors and will be expressed in m/s. This task will require participants to walk whilst counting backwards in integers of three from a randomly generated three digit number. This number will be given three seconds before the participant is prompted to start walking. No instruction will be given on prioritization of tasks and the measure will be repeated five times, with the mean gait speed being recorded.
Measured: Baseline and 24 weeks post intervention
Change in dual Task Cost
The percentage difference between single and dual task performance calculated as = 100* (single-task score - dual-task score)/ single-task
Measured: Baseline and 24 weeks post intervention
Change in five times sit to stand
For this task participants will start off seated on a standard chair 44 cm in height from the ground, with their arms folded across their chest and back against the chair. They will be asked to stand up fully from the chair and sit back down again five times, whilst keeping their arms in the same position. This task will be assessed by timing participants from the prompt to start until they reached a seated position on the fifth repetition.
Measured: Baseline and 24 weeks post intervention
Change in physical functioning from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 3-12 are used to assess physical functioning.
Measured: Baseline and 24 weeks post intervention
Change in bodily pain from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 22 and 23 are used to assess bodily pain.
Measured: Baseline and 24 weeks post intervention
Change in role limitations due to physical health problems from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 13-16 are used to assess role limitations due to physical health problems.
Measured: Baseline and 24 weeks post intervention
Change in role limitations due to personal or emotional problems from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 17-19 are used to assess role limitations due to personal or emotional problems.
Measured: Baseline and 24 weeks post intervention
Change in emotional well-being from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 24-26, 28 and 30 are used to assess emotional well-being.
Measured: Baseline and 24 weeks post intervention
Change in social functioning from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 20 and 32 are used to assess social functioning.
Measured: Baseline and 24 weeks post intervention
Change in energy/fatigue from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 23, 27, 29 and 31 are used to assess energy/fatigue.
Measured: Baseline and 24 weeks post intervention
Change in general health perceptions from short form 36 questionnaire
Participants will be asked to complete the short form 36 questionnaire. All questions are multiple choice and scores range from zero to one hundred, with a higher score indicting a greater health status. Items 1 and 33-36 are used to assess general health perceptions.
Measured: Baseline and 24 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start26 Feb 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- There are two interventions, a multi-nutrient dietary supplement and exercise. The study will have four groups; 1. multi-nutrient supplement and exercise, 2. multi-nutrient non-exercise, 3. placebo supplement and exercise and 4. placebo supplement non-exercise.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Efamol Ltd, Sylvia Waddilove Foundation
- Responsible party
- Principal investigator, Simon Dyall, Bournemouth University
- Investigators
- Simon C Dyall, PhD, Principal investigator, Bournemouth UniversityFotini Tsofliou, PhD, Study director, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228550
- Sponsor's protocol ID
- 002
- Acronym
- MOBILE
- Status last verified
- Jan 2019
- First submitted
- 10 Jul 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Strike SC, Carlisle A, Gibson EL, Dyall SC. A High Omega-3 Fatty Acid Multinutrient Supplement Benefits Cognition and Mobility in Older Women: A Randomized, Double-blind, Placebo-controlled Pilot Study. J Gerontol A Biol Sci Med Sci. 2016 Feb;71(2):236-42. doi: 10.1093/gerona/glv109. Epub 2015 Aug 11.
PubMed 26265727Dyall SC. Long-chain omega-3 fatty acids and the brain: a review of the independent and shared effects of EPA, DPA and DHA. Front Aging Neurosci. 2015 Apr 21;7:52. doi: 10.3389/fnagi.2015.00052. eCollection 2015.
PubMed 25954194Dyall SC. Methodological issues and inconsistencies in the field of omega-3 fatty acids research. Prostaglandins Leukot Essent Fatty Acids. 2011 Nov;85(5):281-5. doi: 10.1016/j.plefa.2011.04.009. Epub 2011 Sep 16.
PubMed 21925854Fairbairn P, Tsofliou F, Johnson A, Dyall SC. Combining a high DHA multi-nutrient supplement with aerobic exercise: Protocol for a randomised controlled study assessing mobility and cognitive function in older women. Prostaglandins Leukot Essent Fatty Acids. 2019 Apr;143:21-30. doi: 10.1016/j.plefa.2019.04.001. Epub 2019 Apr 1.
PubMed 30975379
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Omega-3 Fatty Acid Multinutrient Supplement and Exercise on Mobility and Cognition in Older Women
- ClinicalTrials.gov ID
- NCT03228550
- Acronym / sponsor ID
- MOBILE / 002
- Conditions
- Aging, Cognitive Decline
- Keywords
- omega-3 fatty acid, B vitamins, vitamin E, Phosphatidylserine, Gingko biloba, Gait, Aerobic Exercise, Memory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Efamol Ltd, Sylvia Waddilove Foundation
- Study start
- 26 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Jul 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 study will provide insight into how lifestyle-related interventions, specifically nutrition and exercise can impact the health of older women. The study uses a unique combination of interventions and encapsulates overall health outcomes by measuring both mobility and cognitive function.
The study examines the effects of a combined omega-3 polyunsaturated fatty acid (PUFA) and multi-nutrient supplement on measures of mobility and cognition in women aged 60 years and above. Volunteers for the study will be randomly assigned to one of four groups which are as follows:
- Omega-3 PUFA multi-nutrient supplement and aerobic exercise
- Omega-3 PUFA multi-nutrient supplement and no exercise
- Placebo supplement and aerobic exercise
- Placebo supplement and no exercise
Volunteers undertake the dietary supplementation for a period of 24 weeks. The active dietary supplement contains a daily dosage of 1 g docosahexaenoic acid, 160 mg eicosapentaenoic acid, 240 mg Ginkgo biloba, 60 mg phosphatidylserine, 20 mg d-α tocopherol, 1 mg folic acid, and 20 µg vitamin B12. The placebo supplement contains an iso-calorific oil blend that is typical of the current UK diet. The aerobic exercise consists of two classes per week the final 12 weeks of the study on stationary spinning exercise bikes.
Volunteers attend testing at the beginning and after 24 weeks. Verbal memory, spatial working memory, executive function and processing speed are assessed via a battery of cognitive tests. Mobility testing comprises three walking tests, some under single and dual task paradigms, as well as the five times sit to stand test, a measure of dynamic balance and functional mobility. Volunteers also provide two blood samples, one for fatty acids analysis and the other serum homocysteine levels. Participants also complete health-related quality of life questionnaire, the short form 36 (SF36) questionnaire, food diary and food frequency questionnaire.
Detailed description
Design and Setting:
The study is a randomized semi-blinded, placebo-controlled trial in females aged 60 years and over. The study examines the effects of a high docosahexaenoic acid omega-3 PUFA multi-nutrient dietary supplement and aerobic exercise, both on their own and in combination, on outcomes related to mobility and cognition. All measurements and data collection, as well as the aerobic exercise, take place at the same study site (Bournemouth University, United Kingdom), with participants instructed to consume the dietary supplement at home.
Blinding Randomization and Allocation:
The dietary supplements are packed in identical containers and coded by the Principal Investigator, who has no involvement in the data collection. Omega-3 PUFA capsules have a distinct odor, therefore a small amount of fish oil is added to the placebo capsules to help maintain blinding. A stratified block randomization design is followed with stratification based on frailty classification of non-frail or pre-frail, followed by permuted block randomization. Randomization is achieved by creating a computer-generated list of numbers consisting of four blocks for each stratum referred to without specification of the intervention group (e.g., A, B, C, and D). The list is generated and stored by the Principal Investigator. Due to the nature of the exercise intervention participants are only be blinded to the dietary intervention; however, the experimenters are blinded to the exercise group allocations.
Participants:
Participants are recruited through local newspaper advertisements and public engagements in Bournemouth, U.K. The public advertisements include a brief study description as well as the contact details for the research team. Those who are interested receive a participant information document including the design, procedure, benefits, and risks of the study. Before any data is collected, all participants provide signed written informed consent forms.
All participants are screened to assess frailty status, according to the Fried et al. (2001) criteria. The criteria include low muscle strength, self-reported exhaustion, slowed gait speed, low levels of physical activity, and unintentional weight loss. A score of zero out of the five indicates non-frail, one or two pre-frail, and three or above frail.
The Mini Mental State Examination (MMSE) is performed to exclude participants with cognitive impairment, as this has the potential to go undiagnosed. The test is performed according to British Psychology Society guidelines, and is not used for diagnostic purposes and individual results are not be disclosed to any participant. Participants who score ≤24 are excluded from the study.
Demographic Information:
Information on the age, height, weight, verbal intelligence and medication use is collected from each participant. Information on medications is self-reported, with both type and number of medications recorded. The national adult reading test (NART) is used to assess verbal intelligence. The test requires participants to read aloud 50 pre-prepared words, with scores being calculated based on the number of correct pronunciations. Minor variations from the pronunciations are not penalized as the aim of the test is to assess familiarity with the words rather than exact pronunciation.
Sample Size:
Sample size was determined based on the primary outcome of habitual gait speed. The sample size calculation was based on a difference of 0.08 m/sec with a power of 0.8 and α of 0.05 (two-tailed), based on previous research (Strike et al. 2016). A minimum sample size of 25 participants per group is required to detect an effect size d of 0.8 between experimental groups and the control. An overall recruitment target of 120 participants, 30 per group has been set to allow for drop-outs.
Analysis will be carried out on the basis of groups as randomly assigned. This intention-to-treat analysis will include participants who decide to discontinue treatment, but take part in assessment at 24 weeks. Data analysis will be performed at the conclusion of the intervention and include data collected at baseline and 24 weeks. Data will be tested for normal distribution using Shapiro-Wilk test and Q-Q-plots. Associations between baseline levels of serum homocysteine, whole-blood DHA levels and cognitive and mobility outcomes will be made, as well as changes in DHA and measures of mobility and cognition at the end of the intervention. The treatment effects of the two interventions over time (from pre- and post-measurements) will be analyzed by 2 X 2 ANOVA, with demographic and health information, such as age and NART score, and changes in serum homocysteine and changes in blood fatty acids examined as covariates. This analysis will be performed on all primary and secondary outcomes. Effect size will also be calculated. In all analyses P<0.05 will be considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- There are two interventions, a multi-nutrient dietary supplement and exercise. The study will have four groups; 1. multi-nutrient supplement and exercise, 2. multi-nutrient non-exercise, 3. placebo supplement and exercise and 4. placebo supplement non-exercise.
| Arm | Type | Receives |
|---|---|---|
| Efamol Active 50+ and exercise | Experimental | Dietary Supplement: Efamol Active 50+, Behavioral: Aerobic exerciseEfamol Active 50+ Multinutrient supplement and aerobic exercise |
| Efamol Active 50+ and non-exercise | Experimental | Dietary Supplement: Efamol Active 50+Efamol Active 50+ Multinutrient supplement and non-aerobic exercise |
| Placebo and exercise | Experimental | Behavioral: Aerobic exercise, Dietary Supplement: Placebo multinutrientPlacebo supplement and aerobic exercise |
| Placebo and non-exercise | Experimental | Dietary Supplement: Placebo multinutrientPlacebo supplement and non- exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to walk 50 meters unassisted
- Non-frail or pre-frail according to Fried frailty phenotype
Key exclusion criteria (7 listed)
- Vestibular impairments
- Diagnosed neurological disorder
- Mini mental state examination score of ≤24
- History of lower limb surgery
- Seafood allergy
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 |
|---|---|---|
| Efamol Active 50+1000 mg docosahexaenoic acid, 160 mg eicosapentaenoic acid, 20 µg B12, 1 mg folic acid, 124 mg phosphatidylserine, 240 mg ginkgo biloba standardized leaf extract and 20 mg vitamin E | Dietary supplement | Efamol Active 50+ and exercise, Efamol Active 50+ and non-exercise |
| Aerobic exerciseStatic exercise cycle | Behavioural | Efamol Active 50+ and exercise, Placebo and exercise |
| Placebo multinutrientPlacebo multinutrient supplement | Dietary supplement | Placebo and exercise, Placebo and non-exercise |
Primary outcome
Change in habitual gait speed
Time frame: Baseline and 24 weeks post intervention
Habitual gait speed will be measured using inertial measurement sensors and will be expressed in m/s. Participants will be asked to walk at their normal habitual pace over 13 m. Acceleration and deceleration periods will automatically be excluded from analysis and the measure will be repeated five times with the mean value calculated.
16 secondary outcomes
Change in executive function
Time frame: Baseline and 24 weeks post intervention
Change in verbal memory
Time frame: Baseline and 24 weeks post intervention
Change in processing speed
Time frame: Baseline and 24 weeks post intervention
Change in spatial working memory
Time frame: Baseline and 24 weeks post intervention
Change in fast walking speed
Time frame: Baseline and 24 weeks post intervention
Change in dual task walking speed
Time frame: Baseline and 24 weeks post intervention
Change in dual Task Cost
Time frame: Baseline and 24 weeks post intervention
Change in five times sit to stand
Time frame: Baseline and 24 weeks post intervention
Change in physical functioning from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in bodily pain from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in role limitations due to physical health problems from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in role limitations due to personal or emotional problems from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in emotional well-being from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in social functioning from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in energy/fatigue from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
Change in general health perceptions from short form 36 questionnaire
Time frame: Baseline and 24 weeks post intervention
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 16 Jan 2019.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 26265727Strike SC, Carlisle A, Gibson EL, Dyall SC. A High Omega-3 Fatty Acid Multinutrient Supplement Benefits Cognition and Mobility in Older Women: A Randomized, Double-blind, Placebo-controlled Pilot Study. J Gerontol A Biol Sci Med Sci. 2016 Feb;71(2):236-42. doi: 10.1093/gerona/glv109. Epub 2015 Aug 11.
- Background: PubMed 25954194Dyall SC. Long-chain omega-3 fatty acids and the brain: a review of the independent and shared effects of EPA, DPA and DHA. Front Aging Neurosci. 2015 Apr 21;7:52. doi: 10.3389/fnagi.2015.00052. eCollection 2015.
- Background: PubMed 21925854Dyall SC. Methodological issues and inconsistencies in the field of omega-3 fatty acids research. Prostaglandins Leukot Essent Fatty Acids. 2011 Nov;85(5):281-5. doi: 10.1016/j.plefa.2011.04.009. Epub 2011 Sep 16.
- Derived from this study: PubMed 30975379Fairbairn P, Tsofliou F, Johnson A, Dyall SC. Combining a high DHA multi-nutrient supplement with aerobic exercise: Protocol for a randomised controlled study assessing mobility and cognitive function in older women. Prostaglandins Leukot Essent Fatty Acids. 2019 Apr;143:21-30. doi: 10.1016/j.plefa.2019.04.001. Epub 2019 Apr 1.
- 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.
Simon C Dyall, PhD principal investigator
Bournemouth University
Fotini Tsofliou, PhD study director
Bournemouth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efamol Active 50+ and Aerobic exercise in people with Aging and Cognitive Decline, run by Bournemouth 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 2 inclusion and 7 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 16 Jan 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in habitual gait speed (time frame: Baseline and 24 weeks post intervention). 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 NCT03228550, which also lists 5 linked publications.
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 16 Jan 2019.