None listed
Conditions
Brief summary
Lifestyle risk factors such as lack of regular exercise, poor diet, ageing, excess body weight, high blood fats and high blood sugar levels can lead to overall inflammation, narrowing and hardening of arteries, thus reducing the ability of blood vessels to dilate effectively. A consequence of ineffective dilation of blood vessels is poor blood flow in the brain and this can lead to memory problems, poor concentration or mood. Certain ingredients from food sources such as the long-chain Omega-3 polyunsaturated fatty acids in fish and fish oil are known to benefit heart health by increasing the elasticity of blood vessels, as well as boosting mood and mental performance. Recently, curcumin from the spice turmeric which gives curry its yellow colour is gaining attention for its anti-inflammatory activities. We believe that curcumin can reduce inflammation and in turn enhance blood vessel function. However, their direct effects on the blood vessels in the brain and resultant impact on mental performance are unknown. In this study, we are looking to determine whether supplementing the diet with fish oil or curcumin or a combination of the two nutrients for 16 weeks can enhance the ability of blood vessels in the brain to dilate. We will also explore its effects on blood pressure, blood fats, glucose and markers of inflammation, stiffness of blood vessels, pain, quality of life, mood and mental performance. WHAT ARE THE AIMS OF THIS STUDY? We aim to determine if 16 weeks of fish oil and/or curcumin supplementation can: A. enhance blood flow in the brain in response to demands and thereby improve mood and mental abilities such as short-term memory, attention and concentration B. enhance perception of quality of life. C. reduce perception of pain and stress D. reduce inflammation, blood sugar levels and blood fats. We are seeking a total of 160 overweight or obese men and post-menopausal women who have not had their period for at least 12 months, age 50 – 80 years old and who are relatively inactive (for example less than 150 minutes of exercise on average per week).
Interventions
A 16-week randomised, double-blind, placebo-controlled, 4-arm parallel dietary intervention trial. Participants will be assigned to one of four treatment groups: Group 1: Placebo only; Group 2: Fish oil+ placebo; Group 3: Curcumin + placebo; Group 4: Fish oil + curcumin. The daily dose for fish oil is 4 x 1g (500mg DHA: 100mg EPA) and 2 x 400mg of curcumin. Volunteers will be required to consume their allocated supplement capsules twice a day with meals and note the time of consumption in their
A 16-week randomised, double-blind, placebo-controlled, 4-arm parallel dietary intervention trial. Participants will be assigned to one of four treatment groups: Group 1: Placebo only; Group 2: Fish oil+ placebo; Group 3: Curcumin + placebo; Group 4: Fish oil + curcumin. The daily dose for fish oil is 4 x 1g (500mg DHA: 100mg EPA) and 2 x 400mg of curcumin. Volunteers will be required to consume their allocated supplement capsules twice a day with meals and note the time of consumption in their supplement diary.
Sponsors
Professor Peter Howe
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Age 50-80 years old (women must be >12 months postmenopausal) BMI 25-40kg/m2 Self-reported physical activity level <150min per week Consuming < 2 fish/seafood meals per week Consuming up to 300mg/d of LCn-3 PUFA from fish oil supplements or enriched foods No change in medication type or dose for 1 month before the intervention
Exclusion criteria
Clinic BP >160mmHg systolic or 100mmHg diastolic (determined at screening) Suspected dementia (ACE-III score <82/100) Smokers or currently on nicotine therapy Neurological conditions Heart/kidney/liver disease Insulin therapy Regularly consuming more than four standard alcoholic drinks per day Major depression as diagnosed by a health care professional Illiterate Unwilling to maintain pre-enrolment physical activity levels and dietary habits for the duration of the trial Unwilling to refrain from consuming stimulants before each clinic visit Unwilling to provide a blood sample Have any other medical condition or treatments (including supplements) which, in the investigators’ opinion, may confound the outcome of the study.
Outcome results
None listed