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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-26

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults

NCT01185379

Cognitive Function Mood Well-being +1 more

COMPLETED NA

Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline

NCT00672685

Frail Elderly Subjects

COMPLETED NA

Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.

NCT01817101

Mild Cognitive Impairment

UNKNOWN NA

Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults

NCT01075958

Attention Memory Mood +1 more

COMPLETED

B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.

NCT07312435

Dementia Cognitive Function

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Design and Setting:

The study is a randomized semi-blinded, placebo-controlled trial in females aged 60 years and over. The study examines the effects of a high docosahexaenoic acid omega-3 PUFA multi-nutrient dietary supplement and aerobic exercise, both on their own and in combination, on outcomes related to mobility and cognition. All measurements and data collection, as well as the aerobic exercise, take place at the same study site (Bournemouth University, United Kingdom), with participants instructed to consume the dietary supplement at home.

Blinding Randomization and Allocation:

The dietary supplements are packed in identical containers and coded by the Principal Investigator, who has no involvement in the data collection. Omega-3 PUFA capsules have a distinct odor, therefore a small amount of fish oil is added to the placebo capsules to help maintain blinding. A stratified block randomization design is followed with stratification based on frailty classification of non-frail or pre-frail, followed by permuted block randomization. Randomization is achieved by creating a computer-generated list of numbers consisting of four blocks for each stratum referred to without specification of the intervention group (e.g., A, B, C, and D). The list is generated and stored by the Principal Investigator. Due to the nature of the exercise intervention participants are only be blinded to the dietary intervention; however, the experimenters are blinded to the exercise group allocations.

Participants:

Participants are recruited through local newspaper advertisements and public engagements in Bournemouth, U.K. The public advertisements include a brief study description as well as the contact details for the research team. Those who are interested receive a participant information document including the design, procedure, benefits, and risks of the study. Before any data is collected, all participants provide signed written informed consent forms.

All participants are screened to assess frailty status, according to the Fried et al. (2001) criteria. The criteria include low muscle strength, self-reported exhaustion, slowed gait speed, low levels of physical activity, and unintentional weight loss. A score of zero out of the five indicates non-frail, one or two pre-frail, and three or above frail.

The Mini Mental State Examination (MMSE) is performed to exclude participants with cognitive impairment, as this has the potential to go undiagnosed. The test is performed according to British Psychology Society guidelines, and is not used for diagnostic purposes and individual results are not be disclosed to any participant. Participants who score ≤24 are excluded from the study.

Demographic Information:

Information on the age, height, weight, verbal intelligence and medication use is collected from each participant. Information on medications is self-reported, with both type and number of medications recorded. The national adult reading test (NART) is used to assess verbal intelligence. The test requires participants to read aloud 50 pre-prepared words, with scores being calculated based on the number of correct pronunciations. Minor variations from the pronunciations are not penalized as the aim of the test is to assess familiarity with the words rather than exact pronunciation.

Sample Size:

Sample size was determined based on the primary outcome of habitual gait speed. The sample size calculation was based on a difference of 0.08 m/sec with a power of 0.8 and α of 0.05 (two-tailed), based on previous research (Strike et al. 2016). A minimum sample size of 25 participants per group is required to detect an effect size d of 0.8 between experimental groups and the control. An overall recruitment target of 120 participants, 30 per group has been set to allow for drop-outs.

Analysis will be carried out on the basis of groups as randomly assigned. This intention-to-treat analysis will include participants who decide to discontinue treatment, but take part in assessment at 24 weeks. Data analysis will be performed at the conclusion of the intervention and include data collected at baseline and 24 weeks. Data will be tested for normal distribution using Shapiro-Wilk test and Q-Q-plots. Associations between baseline levels of serum homocysteine, whole-blood DHA levels and cognitive and mobility outcomes will be made, as well as changes in DHA and measures of mobility and cognition at the end of the intervention. The treatment effects of the two interventions over time (from pre- and post-measurements) will be analyzed by 2 X 2 ANOVA, with demographic and health information, such as age and NART score, and changes in serum homocysteine and changes in blood fatty acids examined as covariates. This analysis will be performed on all primary and secondary outcomes. Effect size will also be calculated. In all analyses P\<0.05 will be considered significant.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging Cognitive Decline

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants blinded to dietary intervention, but not exercise. Outcomes assessor blinded to both intervention and exercise group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Efamol Active 50+ and exercise

Efamol Active 50+ Multinutrient supplement and aerobic exercise

Group Type EXPERIMENTAL

Efamol Active 50+

Intervention Type 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

Aerobic exercise

Intervention Type BEHAVIORAL

Static exercise cycle

Efamol Active 50+ and non-exercise

Efamol Active 50+ Multinutrient supplement and non-aerobic exercise

Group Type EXPERIMENTAL

Efamol Active 50+

Intervention Type 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

Placebo and exercise

Placebo supplement and aerobic exercise

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Static exercise cycle

Placebo multinutrient

Intervention Type DIETARY_SUPPLEMENT

Placebo multinutrient supplement

Placebo and non-exercise

Placebo supplement and non- exercise

Group Type EXPERIMENTAL

Placebo multinutrient

Intervention Type DIETARY_SUPPLEMENT

Placebo multinutrient supplement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Aerobic exercise

Static exercise cycle

Intervention Type BEHAVIORAL

Placebo multinutrient

Placebo multinutrient supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes