The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood

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Northumbria University

Status

Completed

Conditions

Cognitive Function

Treatments

Dietary Supplement: 3 g PronovaPure 150:500 EE EU
Dietary Supplement: 3 g PronovaPure 500:200 EE EU
Dietary Supplement: 3 g Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02763514
44N3

Details and patient eligibility

About

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.

Enrollment

337 patients

Sex

All

Ages

25 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 25 to 49 years inclusive
  • Males and females
  • Self-report of good health

Exclusion criteria

  • English is not first language (some of the cognitive tasks have only been validated in native English speakers)
  • Habitual consumption of oily fish exceeds one fish meal per week
  • Habitual consumption of omega-3 dietary supplements in the previous 6 months
  • Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
  • Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)
  • Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
  • Pregnant, trying to get pregnant or breast feeding
  • Body Mass Index outside of the range 18-35 kg/m2
  • High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
  • Currently taking blood pressure medication
  • Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
  • Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
  • Have frequent migraines that require medication (more than or equal to 1 per month)
  • History or current diagnosis of drug/alcohol abuse
  • History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
  • History of neurological or psychiatric illness (excluding depressive illness and anxiety)
  • History of head trauma
  • Sleep disturbances and/or are taking sleep aid medication
  • Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
  • Diagnosis of type I or type II diabetes
  • Heart disorder, or vascular illness
  • Current diagnosis of depression and/or anxiety
  • Over- or under-active thyroid
  • Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
  • Any known active infections
  • Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
  • Current or past breast cancer diagnosis and/or a mastectomy
  • Health condition that would prevent fulfilment of the study requirements
  • Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

337 participants in 3 patient groups, including a placebo group

DHA-enriched oil
Active Comparator group
Description:
3 g PronovaPure 150:500 EE EU
Treatment:
Dietary Supplement: 3 g PronovaPure 150:500 EE EU
EPA-enriched oil
Active Comparator group
Description:
3 g PronovaPure 500:200 EE EU
Treatment:
Dietary Supplement: 3 g PronovaPure 500:200 EE EU
Placebo
Placebo Comparator group
Description:
3 g Olive oil
Treatment:
Dietary Supplement: 3 g Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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