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

Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Coconut flour; Behavioral: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.	9 months
Quality of the diet	To evaluating the effect of treatment on the nutritional quality of the diet	9 months

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Elizabeth P Franco, Nutricionist, Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (ESTIMATE): June 2, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 22, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Diet quality; Cardiovascular risk factor; Coconut flour
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 05155812.2.0000.5257