Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet

Study Overview
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Brief Summary
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In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.

Detailed Description
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The study consists of a diet-intervention in a single group under-free-living conditions. The diet was enriched with 15g of almonds and 15g of walnuts per day for eight weeks, supplied directly to the patient by the researcher. This amounts of walnuts and almonds contain polyunsaturated fatty acids of approximately 2.02g of omega 3 (alpha-linolenic acid) and 11.1g of omega 6 (linoleic acid) mostly. In a period of 14 months, the investigators recruited forty-eight sedentary subjects of 30 to 50 years old, and body mass index between 30 and 34.9 kg/m2, without evidence of chronic degenerative, infectious or neoplastic diseases, neither medication nor actually dietary treatment, and a physical level of exercise < 2 hours/week. All participants gave their written informed consent to participate in the study. The study was approved by the Institutional Ethics Committee of the Universidad de Guanajuato. Collected data included the clinical-nutritional history, 24-hour recalls, and the International Physical Activity Questionnaire was applied to evaluate if subjects were sedentary. The dietary intake evaluation was estimated in kilocalories/day, the amount and type of macronutrients according to the database of United States Department of Agriculture and the National Institute of Public Health (Mexico). In order to evaluate adherence to the diet, volunteers were visited every two weeks to carry out three 24-hour recalls (two on weekdays and one on weekends). Positive Adherence to the diet plan was considered when the food consumption, walnuts and almonds were not modified more than ± 20% of the amount indicated by the researcher. The investigators recorded the anthropometric measures, body composition, and measured serum glucose, lipid profile, insulin, lipocalin 2, high sensitivity C-reactive protein, adiponectin, and fatty acids profile, which were analyzed at the baseline and after dietary intervention.

Official Title
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Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: walnuts and almonds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - obesity grade I Exclusion Criteria: Subjects did not have evidence of chronic degenerative, infectious or neoplastic disease. Lack of adherence to the diet and consumption of walnuts and almonds

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese patients<br>Treatment for 8 weeks | Dietary Supplement: walnuts and almonds<br>* The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolics Changes | fatty acids in percentage | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decreases on all adiposity measures | Weight in kilograms | 8 weeks | 
| Significant decreases on all adiposity measures | height in meters | 8 weeks | 
| Significant decreases on all adiposity measures | waist circumference in centimeters | 8 weeks | 
| Significant decreases on all adiposity measures | hip circumference in centimeters | 8 weeks | 
| Significant decreases on all adiposity measures | fat mass in percentage | 8 weeks | 
| Significant decreases on all adiposity measures | Weight and height will be combined to report BMI in kg/m2 | 8 weeks | 
| Metabolics Changes | Glucose in mg/dL | 8 weeks | 
| Metabolics Changes | total Cholesterol in mg/dL | 8 weeks | 
| Metabolics Changes | LDL-cholesterol in mg/dL | 8 weeks | 
| Metabolics Changes | HDL-cholesterol in mg/dL | 8 weeks | 
| Metabolics Changes | triglycerides in mg/dL | 8 weeks | 
| Metabolics Changes | Lipocalin-2 in mg/mL | 8 weeks | 
| Metabolics Changes | Insulin in pmol/L | 8 weeks | 
| Metabolics Changes | High sensitivity C-reactive protein in mg/L | 8 weeks | 
| Metabolics Changes | adiponectin in microg/mL | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walnuts, almonds, adiponectin, lipocalin-2, obesity