NCT02152111

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

April 4, 2014

Last Update Submit

June 22, 2014

Conditions

ObesityCardiovascular Risk Factor

Keywords

ObesityCoconut flourDiet qualityCardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Lipid profile

    9 months

  • Quality of the diet

    9 months

Study Arms (2)

Dietary Supplement: Coconut flour

EXPERIMENTAL

Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).

Dietary Supplement: Coconut flour

Nutritional Treatment

ACTIVE COMPARATOR

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

Interventions

Coconut flourDIETARY_SUPPLEMENT

Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.

Dietary Supplement: Coconut flour
DietBEHAVIORAL

Patients were instructed to follow the dietary treatment for 6 months.

Nutritional Treatment

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women \> 20 years old BMI \>25 Kg/m²

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Elizabeth P Franco, Nutricionist

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miss

Study Record Dates

First Submitted

April 4, 2014

First Posted

June 2, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06