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

NCT02589756 | Completed DMC

• 1 other identifier: 2015FO7650
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Metabolic Syndrome; Diabetes

Keywords

obesity; persistent organic pollutants; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• persistent organic pollutants

  Measuring of persistent organic pollutants' levels before and after intervention. Blood tests will be obtained at randomization, and six months of follow-up for analysis analysis of environmental pollutants including 21 POPs in g/mol .Six-month follow-up samples will be stored for future analyses.

  6 months

Secondary Outcomes (10)

• waist circumference

  6 months

• Parameter of inflammation CRP (C-reactive protein)

  6 months

• Parameter of insulin resistance HOMA index

  6 months

• C-peptide

  6 months

• Insulin

  6 months

Study Arms (3)

The fatty fish group

EXPERIMENTAL

Participants will eat fatty fish and avoiding nuts)

Other: The nut group; Other: The control group

The nut group

EXPERIMENTAL

Participants who will avoid fatty fish

Other: The fatty fish group; Other: The control group

The control group

PLACEBO COMPARATOR

Participants who will avoid both fatty fish and nuts

Other: The fatty fish group; Other: The nut group

Interventions

The fatty fish group OTHER

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.

The control group; The nut group

The nut group OTHER

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.

The control group; The fatty fish group

The control group OTHER

After the baseline the control group will consume their usual diet, asked to avoid fatty fish and nuts.

The fatty fish group; The nut group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, Norway

Location

Related Publications (5)

• Ngwa EN, Kengne AP, Tiedeu-Atogho B, Mofo-Mato EP, Sobngwi E. Persistent organic pollutants as risk factors for type 2 diabetes. Diabetol Metab Syndr. 2015 Apr 30;7:41. doi: 10.1186/s13098-015-0031-6. eCollection 2015.

  PMID: 25987904 BACKGROUND

• Schecter A, Colacino J, Haffner D, Patel K, Opel M, Papke O, Birnbaum L. Perfluorinated compounds, polychlorinated biphenyls, and organochlorine pesticide contamination in composite food samples from Dallas, Texas, USA. Environ Health Perspect. 2010 Jun;118(6):796-802. doi: 10.1289/ehp.0901347. Epub 2010 Feb 10.

  PMID: 20146964 BACKGROUND

• Tan SY, Dhillon J, Mattes RD. A review of the effects of nuts on appetite, food intake, metabolism, and body weight. Am J Clin Nutr. 2014 Jul;100 Suppl 1:412S-22S. doi: 10.3945/ajcn.113.071456. Epub 2014 Jun 11.

  PMID: 24920033 BACKGROUND

• Orem A, Yucesan FB, Orem C, Akcan B, Kural BV, Alasalvar C, Shahidi F. Hazelnut-enriched diet improves cardiovascular risk biomarkers beyond a lipid-lowering effect in hypercholesterolemic subjects. J Clin Lipidol. 2013 Mar-Apr;7(2):123-31. doi: 10.1016/j.jacl.2012.10.005. Epub 2012 Oct 26.

  PMID: 23415431 BACKGROUND

• Dusanov S, Svendsen M, Ruzzin J, Kiviranta H, Gulseth HL, Klemsdal TO, Tonstad S. Effect of fatty fish or nut consumption on concentrations of persistent organic pollutants in overweight or obese men and women: A randomized controlled clinical trial. Nutr Metab Cardiovasc Dis. 2020 Mar 9;30(3):448-458. doi: 10.1016/j.numecd.2019.11.006. Epub 2019 Nov 21.

  PMID: 32008913 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kare I Birkeland, MD, Ph.D

  Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: October 28, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 11, 2017
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

NO (1)