Omega-3 Fatty Acids and Exercise on Mobility and Cognition in Older Women
NCT03228550 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-01-16
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
Interventions
- 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
- DIETARY_SUPPLEMENT
-
Placebo multinutrient
Placebo multinutrient supplement
Sponsors & Collaborators
-
Efamol Ltd
collaborator INDUSTRY -
Sylvia Waddilove Foundation
collaborator UNKNOWN -
Bournemouth University
lead OTHER
Principal Investigators
-
Simon C Dyall, PhD · Bournemouth University
-
Fotini Tsofliou, PhD · Bournemouth University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-02-26
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- United Kingdom
Study Locations
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