Clinical trial NCT03211754: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Walnuts
almonds
adiponectin
lipocalin-2
obesity
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Metabolics Changes
timeFrame: 8 weeks
Secondary outcomes:
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Significant decreases on all adiposity measures
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
measure: Metabolics Changes
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
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