Cardiovascular Risk Factor and Kidney Related Biomarkers Clinical Trial
Official title:
The Impact of Fish and Walnut Consumption on Cardiovascular Risk Factors in Overweight and Obese Females: A Randomized Clinical Trial
| Verified date | March 2017 |
| Source | Isfahan University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 99 |
| Est. completion date | January 20, 2017 |
| Est. primary completion date | November 21, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - over weight or obese Exclusion Criteria: - have any diseases |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Isfahan University of Medical Sciences |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | body mass index | BMI was calculated as body weight in kg divided by height in m2. | 12 week | |
| Other | 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 | |
| Other | Hs-CRP | Hs-CRP was measured by the Immunoturbidimetry method with a polyclonal antibody (Pars Azmoon Inc). | 12 week | |
| Other | 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 | |
| Primary | 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 | height | meter | 12 week | |
| Secondary | weight | kg | 12 week | |
| Secondary | BUN | 12 WEEK | ||
| Secondary | creatinine | 12 WEEK |