CompletedNot Applicable

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

Norway120 participantsStarted 2015-09

Plain-language summary

Obesity represents one of the most important public health challenges for the societies. Although excess energy intake and physical inactivity are major causes of obesity and cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs) with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic reviews and meta-analyses conducted in recent years strongly support a protective association between eating nuts and CVD. The investigators will conduct a randomized controlled clinical trial in adults. The main research questions are: a. Does consumption of fatty fish increase levels of POPs in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? b. Does consumption of fatty fish affect markers of cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? c. Does consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and 2. to a group consuming fatty fish. Clinical significance of study: If an increase in POP levels is seen, and correlates with cardiometabolic risks, this may indicate the need to look further at a causal relation between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish, this could be important dietary information for populations at high risk of CVD.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women aged 40 to 65 years * BMI in the overweight (25-29.9) or obese (30-34.9) * Range and components of metabolic syndrome (waist circumference \>102 cm for men or \>94 cm for women; fasting glucose \>5.6 mmol/l, HDL cholesterol \<1.3 for women or \<1.0 for men, and triglycerides \>1.7 mmol/l) * Fertile women are required to use reliable contraception Exclusion Criteria: * Cigarette smoking * Diabetes mellitus * Allergy or dislike of fish * allergy or dislike of nuts * chronic disease * morbid obesity due to ethical reasons and weight fluctuations * eating disorder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

persistent organic pollutants

Timeframe: 6 months

Trial details

NCT IDNCT02589756

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

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