Omega-3 and Cardiovascular Risk Factors and Kidney Related Biomarkers

NCT03197220 | Completed

• 1 other identifier: omega-3
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, 99 overweight or obese women that referred to the Clinic Nutrition to lose weight were randomly divided into three groups according to body mass index (BMI) by random-number table (figure1). We attempted to match all three groups for BMI, probable medications, and age. Subjects were excluded if they had risk factors of cardiovascular diseases or allergic reactions to fish or walnut, or received lowering blood glucose or lipid profile agents. Also, participants with weak economic status could not enter to this study (due to the high cost of fish and walnuts). Before the start of this study, the information in the form of questionnaire about demographic, medical history, and medication use, was completed. Participants were aware about overview of this study, and completed the consent form. The NATIONAL INSTITUTED FOR MEDICAL RESEARCH DEVELOPMENT (NIMAD), approved all procedures involving human subjects. The study has been done in accordance with the ethical standards in declaration of Helsinki. Then all of the three groups received a low-calorie diet in order to lose weight. The distribution of macronutrients was similar in three groups (carbohydrate 55%, fat 33%, and protein 17%). The amount of different fatty acids (saturated, unsaturated with mono double bond, and polyunsaturated fatty acids) intake in these diets was the same but the sources of omega-3 between these groups were different. In the first group, subjects were instructed to consume 300 gram fatty fish, such as Salmon fish during a week in two separated meals (each meal 150 gr fatty fish) and to avoid consumption of plant sources of omega-3 (soybean oil, canola, flaxseed and walnuts). In the second group, subjects were asked to consume walnuts three times a week and each time two walnuts (totally 18 walnuts/wk) and avoid the consumption of fish. And in the third group, subjects were recommended to consume 150 g fatty fish during a week and nine walnuts. The amount of omega-3 fatty acids considered in this study covered the typical recommended intake (0.3 to 0.5 g/d of EPA+DHA and 0.8 to 1.1 g/d of ALA)(14). Dietary intakes of all patients were controlled by a dietitian and they were followed for 12 weeks. Dietary intakes were assessed by three dietary records (one weekend and two week days).

Conditions

Cardiovascular Risk Factor and Kidney Related Biomarkers

Outcome Measures

Primary Outcomes (1)

• the change of biochemical factor levels

  Systolic and diastolic blood pressures (SBP and DBP) will measured twice after 15 min of rest in sitting and comfortably position using a standard mercury sphygmomanometer. Blood sugar (FBS) will measured on the day of blood sampling and quantified by colorimetric method by the glucose oxidize technique. hs-CRP will measured by The Immunoturbidimetry method with with a polyclonal antibody (Pars Azmoon Inc). Serum concentrations of, high-density lipoprotein cholesterol(HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) will quantified using commercially available enzymatic reagents (Pars Azmoon, Tehran, Iran) adapted to an autoanalyzer system (Selectra E, Vitalab, Holliston, the Netherlands).

  12 weeks

Secondary Outcomes (4)

• height

  12 week

• weight

  12 week

• BUN

  12 WEEK

• creatinine

  12 WEEK

Other Outcomes (4)

• body mass index

  12 week

• physical activities

  12 week

• Hs-CRP

  12 week

Study Arms (3)

fish

EXPERIMENTAL

Other: fish

walnut

EXPERIMENTAL

Other: walnut

fish-walnut

EXPERIMENTAL

Other: fish-walnut

Interventions

fish OTHER

300 gr/week fish

fish

walnut OTHER

18 walnut per week

walnut

fish-walnut OTHER

150 gr fish and 9 walnut per week

fish-walnut

Eligibility Criteria

• Gender Eligibility Details: overweight or obese female that referred to the Clinic Nutrition to lose weight
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• over weight or obese

You may not qualify if:

• have any diseases

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Related Publications (1)

• Fatahi S, Haghighatdoost F, Larijani B, Azadbakht L. Effect of Weight Reduction Diets Containing Fish, Walnut or Fish plus Walnut on Cardiovascular Risk Factors in Overweight and Obese Women. Arch Iran Med. 2019 Oct 1;22(10):574-583.

  PMID: 31679359 DERIVED

MeSH Terms

Interventions

In Situ Hybridization, Fluorescence; PR-10 protein, walnut birch pollen

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: June 23, 2017
• Study Start: November 22, 2015
• Primary Completion: November 21, 2016
• Study Completion: January 20, 2017
• Last Updated: April 7, 2020

Record last verified: 2017-03