Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants
NCT02589756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2020-05-11
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.
Conditions
Interventions
- OTHER
-
The fatty fish group
At inclusion demographic information recorded, including length of breastfeeding for women. Thereafter, participants will start with a run-in period of two weeks where they will be asked not to consume salmon, mackerel, sardines or other fatty fish or nuts providing a dietary baseline. At baseline, subjects will be randomized to a fish, nuts or control group. The fish group will be asked to consume three to four portions weekly. The fish will be eaten at the main meal and in sandwiches for a total of 600 grams weekly for 6 months. This group will avoid eating nuts. The nut group will consume equal amount of energy (\~1400 kcal ) for weekly use for 6 months. This group will avoid eating fatty fish. The control group will consume their usual diet, but asked to avoid fatty fish and nuts.
- OTHER
-
The nut group
At baseline (conditions for baseline are the same in all three groups) the nut group will consume equal amount of energy (\~1400 kcal \~100 grams walnuts, \~50 grams hazelnuts and \~50 grams almonds/week).The nuts will be provided free of charge for the six months. This group will avoid eating fatty fish.
- OTHER
-
The control group
After the baseline the control group will consume their usual diet, asked to avoid fatty fish and nuts.
Sponsors & Collaborators
-
Oslo University Hospital
lead OTHER
Principal Investigators
-
Kare I Birkeland, MD, Ph.D · Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Norway
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2017-09-30
- Completion
- 2017-09-11
Countries
- Norway
Study Locations
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