Omega-3 and Cardiovascular Risk Factors and Kidney Related Biomarkers

The Impact of Fish and Walnut Consumption on Cardiovascular Risk Factors in Overweight and Obese Females: A Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor and Kidney Related Biomarkers
• Intervention / Treatment: Other: fish; Other: walnut; Other: fish-walnut

Detailed Description

This is a clinical trial which conducted on over weight and obese female.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• over weight or obese

Exclusion Criteria:

• have any diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fish	Other: fish; 300 gr/week fish
Experimental: walnut	Other: walnut; 18 walnut per week
Experimental: fish-walnut	Other: fish-walnut; 150 gr fish and 9 walnut per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
height	meter	12 week
weight	kg	12 week
BUN		12 WEEK
creatinine		12 WEEK

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	BMI was calculated as body weight in kg divided by height in m2.	12 week
physical activities	We asked participants to record the duration of all physical activities in 24h for three days at weeks 3, 6, 9 and 12 of the intervention. Then the recorded physical activities were multiplied by the relevant metabolic equivalents task hours per day (MET-h/d) and were calculated the MET.h/d values of all activities to obtain the value of physical activity in a day.	12 week
Hs-CRP	Hs-CRP was measured by the Immunoturbidimetry method with a polyclonal antibody (Pars Azmoon Inc).	12 week
high-density lipoprotein cholesterol (HDL-C), LDL-C and TG	were quantified using commercially available enzymatic reagents (Pars Azmoon, Tehran, Iran) adapted to an autoanalyzer system (Selectra E, Vitalab, Holliston, the Netherlands).	12 week

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2015
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): January 20, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: omega-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No