Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walnuts and almonds
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring Walnuts, almonds, adiponectin, lipocalin-2, obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Obese patients
Arm Description
Treatment for 8 weeks
Outcomes
Primary Outcome Measures
Metabolics Changes
fatty acids in percentage
Secondary Outcome Measures
Significant decreases on all adiposity measures
Weight in kilograms
Significant decreases on all adiposity measures
height in meters
Significant decreases on all adiposity measures
waist circumference in centimeters
Significant decreases on all adiposity measures
hip circumference in centimeters
Significant decreases on all adiposity measures
fat mass in percentage
Significant decreases on all adiposity measures
Weight and height will be combined to report BMI in kg/m2
Metabolics Changes
Glucose in mg/dL
Metabolics Changes
total Cholesterol in mg/dL
Metabolics Changes
LDL-cholesterol in mg/dL
Metabolics Changes
HDL-cholesterol in mg/dL
Metabolics Changes
triglycerides in mg/dL
Metabolics Changes
Lipocalin-2 in mg/mL
Metabolics Changes
Insulin in pmol/L
Metabolics Changes
High sensitivity C-reactive protein in mg/L
Metabolics Changes
adiponectin in microg/mL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03211754
Brief Title
Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
Official Title
Changes on Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Walnuts, almonds, adiponectin, lipocalin-2, obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese patients
Arm Type
Experimental
Arm Description
Treatment for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
walnuts and almonds
Intervention Description
The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks
Primary Outcome Measure Information:
Title
Metabolics Changes
Description
fatty acids in percentage
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Significant decreases on all adiposity measures
Description
Weight in kilograms
Time Frame
8 weeks
Title
Significant decreases on all adiposity measures
Description
height in meters
Time Frame
8 weeks
Title
Significant decreases on all adiposity measures
Description
waist circumference in centimeters
Time Frame
8 weeks
Title
Significant decreases on all adiposity measures
Description
hip circumference in centimeters
Time Frame
8 weeks
Title
Significant decreases on all adiposity measures
Description
fat mass in percentage
Time Frame
8 weeks
Title
Significant decreases on all adiposity measures
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
8 weeks
Title
Metabolics Changes
Description
Glucose in mg/dL
Time Frame
8 weeks
Title
Metabolics Changes
Description
total Cholesterol in mg/dL
Time Frame
8 weeks
Title
Metabolics Changes
Description
LDL-cholesterol in mg/dL
Time Frame
8 weeks
Title
Metabolics Changes
Description
HDL-cholesterol in mg/dL
Time Frame
8 weeks
Title
Metabolics Changes
Description
triglycerides in mg/dL
Time Frame
8 weeks
Title
Metabolics Changes
Description
Lipocalin-2 in mg/mL
Time Frame
8 weeks
Title
Metabolics Changes
Description
Insulin in pmol/L
Time Frame
8 weeks
Title
Metabolics Changes
Description
High sensitivity C-reactive protein in mg/L
Time Frame
8 weeks
Title
Metabolics Changes
Description
adiponectin in microg/mL
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Anthropometric Measures and Anti-inflammatory Markers by a PUFAs Enriched Diet
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