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

NCT03228550 | Completed Phase 2

• 1 other identifier: 002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Cognitive Decline

Keywords

omega-3 fatty acid; B vitamins; vitamin E; Phosphatidylserine; Gingko biloba; Gait; Aerobic Exercise; Memory; Cognitive function

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 24 weeks post intervention

Secondary Outcomes (16)

• Change in executive function

  Baseline and 24 weeks post intervention

• Change in verbal memory

  Baseline and 24 weeks post intervention

• Change in processing speed

  Baseline and 24 weeks post intervention

• Change in spatial working memory

  Baseline and 24 weeks post intervention

• Change in fast walking speed

  Baseline and 24 weeks post intervention

Other Outcomes (12)

• Change in whole-blood fatty acid content

  Baseline and 24 weeks post intervention

• Change in serum homocysteine

  Baseline and 24 weeks post intervention

• Change in stride length

  Baseline and 24 weeks post intervention

Study Arms (4)

Efamol Active 50+ and exercise

EXPERIMENTAL

Efamol Active 50+ Multinutrient supplement and aerobic exercise

Dietary Supplement: Efamol Active 50+; Behavioral: Aerobic exercise

Efamol Active 50+ and non-exercise

EXPERIMENTAL

Efamol Active 50+ Multinutrient supplement and non-aerobic exercise

Dietary Supplement: Efamol Active 50+

Placebo and exercise

EXPERIMENTAL

Placebo supplement and aerobic exercise

Behavioral: Aerobic exercise; Dietary Supplement: Placebo multinutrient

Placebo and non-exercise

EXPERIMENTAL

Placebo supplement and non- exercise

Dietary Supplement: Placebo multinutrient

Interventions

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

Efamol Active 50+ and exercise; Efamol Active 50+ and non-exercise

Aerobic exercise BEHAVIORAL

Static exercise cycle

Efamol Active 50+ and exercise; Placebo and exercise

Placebo multinutrient DIETARY_SUPPLEMENT

Placebo multinutrient supplement

Placebo and exercise; Placebo and non-exercise

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bournemouth University: lead
• Efamol Ltd: collaborator
• Sylvia Waddilove Foundation: collaborator

Study Sites (1)

Bournemouth University

Bournemouth, Dorset, BH1 3LT, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 11253156 BACKGROUND

• Strike 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.

  PMID: 26265727 BACKGROUND

• Dyall 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.

  PMID: 25954194 BACKGROUND

• Dyall 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.

  PMID: 21925854 BACKGROUND

• Fairbairn 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.

  PMID: 30975379 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Simon C Dyall, PhD

  Bournemouth University

  PRINCIPAL INVESTIGATOR

• Fotini Tsofliou, PhD

  Bournemouth University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants blinded to dietary intervention, but not exercise. Outcomes assessor blinded to both intervention and exercise group.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Academic

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 25, 2017
• Study Start: February 26, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)