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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228550 on ClinicalTrials.gov