Back to resultsHipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight
Primary Purpose
Obesity, Cardiovascular Risk Factor
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coconut flour
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Coconut flour, Diet quality, Cardiovascular risk factor
Eligibility Criteria
Inclusion Criteria:
women > 20 years old BMI >25 Kg/m²
Exclusion Criteria:
Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dietary Supplement: Coconut flour
Nutritional Treatment
Arm Description
Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).
All patients received an individualized diet plan and balanced. The diet was calculated to the nutritional status and the protein 15-20% of total energy value, lipids 25-30% of daily energy intake and carbohydrate 50-60% of total energy value
Outcomes
Primary Outcome Measures
Anthropometry
To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity
Secondary Outcome Measures
Lipid profile
To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Quality of the diet
To evaluating the effect of treatment on the nutritional quality of the diet
Full Information
NCT ID
NCT02152111
First Posted
April 4, 2014
Last Updated
June 22, 2014
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT02152111
Brief Title
Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight
Official Title
Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.
Detailed Description
This is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. In order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Risk Factor
Keywords
Obesity, Coconut flour, Diet quality, Cardiovascular risk factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Supplement: Coconut flour
Arm Type
Experimental
Arm Description
Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).
Arm Title
Nutritional Treatment
Arm Type
Active Comparator
Arm Description
All patients received an individualized diet plan and balanced. The diet was calculated to the nutritional status and the protein 15-20% of total energy value, lipids 25-30% of daily energy intake and carbohydrate 50-60% of total energy value
Intervention Type
Dietary Supplement
Intervention Name(s)
Coconut flour
Intervention Description
Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Patients were instructed to follow the dietary treatment for 6 months.
Primary Outcome Measure Information:
Title
Anthropometry
Description
To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Lipid profile
Description
To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Time Frame
9 months
Title
Quality of the diet
Description
To evaluating the effect of treatment on the nutritional quality of the diet
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women > 20 years old BMI >25 Kg/m²
Exclusion Criteria:
Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth P Franco, Nutricionist
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight
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