Skip to main content
OpenTrials
Completed

NCT Number: NCT03197220

Omega-3 and Cardiovascular Risk Factors and Kidney Related Biomarkers

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).

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over weight or obese

Exclusion criteria

  • have any diseases

Treatment and study plan

fish

Other

300 gr/week fish

Walnut

Other

18 walnut per week

fish-walnut

Other

150 gr fish and 9 walnut per week

Primary outcomes

  1. the change of biochemical factor levels

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. height

    Time frame: 12 week

    meter

  2. weight

    Time frame: 12 week

    kg

  3. BUN

    Time frame: 12 WEEK

  4. creatinine

    Time frame: 12 WEEK

Other outcomes

  1. body mass index

    Time frame: 12 week

    BMI was calculated as body weight in kg divided by height in m2.

  2. physical activities

    Time frame: 12 week

    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.

  3. Hs-CRP

    Time frame: 12 week

    Hs-CRP was measured by the Immunoturbidimetry method with a polyclonal antibody (Pars Azmoon Inc).

  4. high-density lipoprotein cholesterol (HDL-C), LDL-C and TG

    Time frame: 12 week

    were quantified using commercially available enzymatic reagents (Pars Azmoon, Tehran, Iran) adapted to an autoanalyzer system (Selectra E, Vitalab, Holliston, the Netherlands).

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.