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Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight

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ClinicalTrials.gov Identifier: NCT02152111
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Elizabeth de Paula Franco, Universidade Federal do Rio de Janeiro

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.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Risk Factor Dietary Supplement: Coconut flour Behavioral: Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Dietary Supplement: Coconut flour
Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).
Dietary Supplement: Coconut flour
Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.

Active Comparator: Nutritional Treatment
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
Behavioral: Diet
Patients were instructed to follow the dietary treatment for 6 months.




Primary Outcome Measures :
  1. Anthropometry [ Time Frame: 9 months ]
    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 :
  1. Lipid profile [ Time Frame: 9 months ]
    To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.

  2. Quality of the diet [ Time Frame: 9 months ]
    To evaluating the effect of treatment on the nutritional quality of the diet



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152111


Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Elizabeth P Franco, Nutricionist Universidade Federal do Rio de Janeiro
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Responsible Party: Elizabeth de Paula Franco, Miss, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02152111    
Other Study ID Numbers: 05155812.2.0000.5257
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Keywords provided by Elizabeth de Paula Franco, Universidade Federal do Rio de Janeiro:
Obesity
Coconut flour
Diet quality
Cardiovascular risk factor
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms