Omega-3 and Cardiovascular Risk Factors and Kidney Related Biomarkers

NCT ID: NCT03197220

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-22
• Study Completion Date: 2017-01-20

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).

Detailed Description

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

Conditions

Cardiovascular Risk Factor and Kidney Related Biomarkers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fish

Group Type: EXPERIMENTAL

fish

Intervention Type: OTHER

300 gr/week fish

walnut

Group Type: EXPERIMENTAL

walnut

Intervention Type: OTHER

18 walnut per week

fish-walnut

Group Type: EXPERIMENTAL

fish-walnut

Intervention Type: OTHER

150 gr fish and 9 walnut per week

Interventions

fish

300 gr/week fish

Intervention Type: OTHER

walnut

18 walnut per week

Intervention Type: OTHER

fish-walnut

150 gr fish and 9 walnut per week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• over weight or obese

Exclusion Criteria

• have any diseases

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Leila Azadbakht

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31679359 (View on PubMed)

Other Identifiers

omega-3

Identifier Type: -

Identifier Source: org_study_id