Omega-3 Fatty Acids and Exercise on Mobility and Cognition in Older Women
NCT03228550, Phase 2, Completed, Bournemouth University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Omega-3 Fatty Acids and Exercise on Mobility and Cognition in Older Women | ClinicalTrials.gov |
| NCT number | NCT03228550 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Bournemouth University | ClinicalTrials.gov |
| Conditions | Aging, Cognitive Decline | ClinicalTrials.gov |
| Interventions | Efamol Active 50+, Aerobic exercise, Placebo multinutrient | ClinicalTrials.gov |
| First posted | 2017-07-25 | ClinicalTrials.gov |
| Last updated | 2019-01-16 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in habitual gait speed | 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. | ClinicalTrials.gov |
| Secondary | Change in executive function | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in verbal memory | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in processing speed | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in spatial working memory | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in fast walking speed | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in dual task walking speed | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in dual Task Cost | Baseline and 24 weeks post intervention | The percentage difference between single and dual task performance calculated as = 100\* (single-task score - dual-task score)/ single-task | ClinicalTrials.gov |
| Secondary | Change in five times sit to stand | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in physical functioning from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in bodily pain from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in role limitations due to physical health problems from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in role limitations due to personal or emotional problems from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in emotional well-being from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in social functioning from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in energy/fatigue from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Secondary | Change in general health perceptions from short form 36 questionnaire | Baseline and 24 weeks post intervention | 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. | ClinicalTrials.gov |
| Other | Change in whole-blood fatty acid content | Baseline and 24 weeks post intervention | Whole-blood fatty acid content will be analyzed from finger-prick samples from non-fasted participants. | ClinicalTrials.gov |
| Other | Change in serum homocysteine | Baseline and 24 weeks post intervention | Serum homocysteine levels will be measured by a commercially available enzyme-linked immunosorbent assay (ELISA). | ClinicalTrials.gov |
| Other | Change in stride length | Baseline and 24 weeks post intervention | Change in stride length will be recorded on each gait outcome, using inertial measurement sensors, to give an insight into which aspects of the gait cycle are driving any changes that occur. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)