Effects of Moderate Consumption of Lean Fish on Weight Loss

Study Overview
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Brief Summary
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the aim of present study is to compare the specific effects moderate consumption of lean fish on weight loss of healthy obese and overweight female adults, while participants follow energy-restricted diets also to investigate the effects of this intervention on carbohydrate and lipid profiles, as cardiometabolic risk factors.

Official Title
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Effects of Moderate Consumption Lean Fish on Weight Loss of Overweight and Obese Women During a Weight Loss Program, a 24 Week Randomized Controlled Trial

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Fish group
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female 18-45 years of age. Body mass index (BMI) between 27.5-35 kg/m² Must be able to have moderate exercise. Must be interested to lose weight Exclusion Criteria: Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. Taking medications that could affect metabolism or change body weight. Report heart problems, chest pain, and cancer within the last five years. Use of supplements containing n-3 fatty acids, calcium or vitamin-D during the last 3 months. Consumption of fish and sea foods regularly Smoking Menopause Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish group<br>subjects will have 3 x 150 g lean fish/ week at main meal | Behavioral: Fish group<br>* Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal<br>* Other names: FG;|
| Experimental: Control group<br>subjects will have no seafood. | Behavioral: Control group<br>* Control group will have hypo-energetic diet in which subjects have no seafood.<br>* Other names: CG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | kg | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | cm | 24 Weeks | 
| fasting plasma glucose | mmol/l | 24 Weeks | 
| serum insulin level | mU/l | 24 Weeks | 
| insulin resistance (HOMA-IR) | score | 24 Weeks | 
| glycosylated hemoglobin (HbA1c) | percentage (%) | 24 Weeks | 
| lipid profiles | mmol/l | 24 Weeks | 
| liver enzymes (SGOT, SGPT) | U/l | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, lean fish, weight loss