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Omega-3 Fatty Acids and Exercise on Mobility and Cognition in Older Women (MOBILE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228550
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Efamol Ltd
Sylvia Waddilove Foundation
Information provided by (Responsible Party):
Simon Dyall, Bournemouth University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Aging Cognitive Decline Dietary Supplement: Efamol Active 50+ Behavioral: Aerobic exercise Dietary Supplement: Placebo multinutrient Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants blinded to dietary intervention, but not exercise. Outcomes assessor blinded to both intervention and exercise group.
Primary Purpose: Prevention
Official Title: Investigating the Effects of Omega-3 Fatty Acid Multinutrient Supplement and Exercise on Mobility and Cognition in Older Women
Actual Study Start Date : February 26, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Efamol Active 50+ and exercise
Efamol Active 50+ Multinutrient supplement and aerobic exercise
Dietary Supplement: 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

Behavioral: Aerobic exercise
Static exercise cycle

Experimental: Efamol Active 50+ and non-exercise
Efamol Active 50+ Multinutrient supplement and non-aerobic exercise
Dietary Supplement: 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

Experimental: Placebo and exercise
Placebo supplement and aerobic exercise
Behavioral: Aerobic exercise
Static exercise cycle

Dietary Supplement: Placebo multinutrient
Placebo multinutrient supplement

Experimental: Placebo and non-exercise
Placebo supplement and non- exercise
Dietary Supplement: Placebo multinutrient
Placebo multinutrient supplement




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in executive function [ Time Frame: 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.

  2. Change in verbal memory [ Time Frame: 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.

  3. Change in processing speed [ Time Frame: 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.

  4. Change in spatial working memory [ Time Frame: 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.

  5. Change in fast walking speed [ Time Frame: 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.

  6. Change in dual task walking speed [ Time Frame: 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.

  7. Change in dual Task Cost [ Time Frame: 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

  8. Change in five times sit to stand [ Time Frame: 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.

  9. Change in physical functioning from short form 36 questionnaire [ Time Frame: 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.

  10. Change in bodily pain from short form 36 questionnaire [ Time Frame: 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.

  11. Change in role limitations due to physical health problems from short form 36 questionnaire [ Time Frame: 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.

  12. Change in role limitations due to personal or emotional problems from short form 36 questionnaire [ Time Frame: 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.

  13. Change in emotional well-being from short form 36 questionnaire [ Time Frame: 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.

  14. Change in social functioning from short form 36 questionnaire [ Time Frame: 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.

  15. Change in energy/fatigue from short form 36 questionnaire [ Time Frame: 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.

  16. Change in general health perceptions from short form 36 questionnaire [ Time Frame: 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.


Other Outcome Measures:
  1. Change in whole-blood fatty acid content [ Time Frame: Baseline and 24 weeks post intervention ]
    Whole-blood fatty acid content will be analyzed from finger-prick samples from non-fasted participants.

  2. Change in serum homocysteine [ Time Frame: Baseline and 24 weeks post intervention ]
    Serum homocysteine levels will be measured by a commercially available enzyme-linked immunosorbent assay (ELISA).

  3. Change in stride length [ Time Frame: 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.

  4. Change in cadence [ Time Frame: Baseline and 24 weeks post intervention ]
    Change in cadence will be recorded on each gait outcome, inertial measurement sensors, to give an insight into which aspects of the gait cycle are driving any changes that occur.

  5. Change in double support phase percentage [ Time Frame: Baseline and 24 weeks post intervention ]
    Change in double support phase percentage will be recorded on each gait outcome, inertial measurement sensors, to give an insight into which aspects of the gait cycle are driving any changes that occur.

  6. Change in stride length variability [ Time Frame: Baseline and 24 weeks post intervention ]
    Change in stride length variability will be recorded on each gait outcome, inertial measurement sensors, to give an insight into which aspects of the gait cycle are driving any changes that occur.

  7. Physical activity levels [ Time Frame: Baseline and 24 weeks post intervention ]
    Physical activity levels will be assessed using the previously validated community health activities program for seniors questionnaire.

  8. Dietary energy intake [ Time Frame: Baseline and 24 weeks post intervention ]
    Dietary energy intake will be assessed using a estimated three day diet diary. Diet diaries will be analyzed using nutritional composition analysis software and result expressed as kilocalories per day.

  9. Carbohydrate intake from diet [ Time Frame: Baseline and 24 weeks post intervention ]
    Carbohydrate intake will be assessed using a estimated three day diet diary. Diet diaries will be analyzed using nutritional composition analysis software and result expressed as grams per day.

  10. Protein intake from diet [ Time Frame: Baseline and 24 weeks post intervention ]
    Protein intake will be assessed using a estimated three day diet diary. Diet diaries will be analyzed using nutritional composition analysis software and result expressed as grams per day.

  11. Fat intake from diet [ Time Frame: Baseline and 24 weeks post intervention ]
    Fat intake will be assessed using a estimated three day diet diary. Diet diaries will be analyzed using nutritional composition analysis software and result expressed as grams per day.

  12. Omega-3 polyunsaturated fatty acid intake from diet [ Time Frame: Baseline and 24 weeks post intervention ]
    Omega-3 polyunsaturated fatty acid intake will be assessed using a previously validated 17 item food frequency questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to walk 50 meters unassisted
  • Non-frail or pre-frail according to Fried frailty phenotype

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228550


Locations
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United Kingdom
Bournemouth University
Bournemouth, Dorset, United Kingdom, BH1 3LT
Sponsors and Collaborators
Bournemouth University
Efamol Ltd
Sylvia Waddilove Foundation
Investigators
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Principal Investigator: Simon C Dyall, PhD Bournemouth University
Study Director: Fotini Tsofliou, PhD Bournemouth University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon Dyall, Principal Academic, Bournemouth University
ClinicalTrials.gov Identifier: NCT03228550     History of Changes
Other Study ID Numbers: 002
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Dyall, Bournemouth University:
omega-3 fatty acid
B vitamins
vitamin E
Phosphatidylserine
Gingko biloba
Gait
Aerobic Exercise
Memory
Cognitive function
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamins
Evening primrose oil
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Dermatologic Agents