Effect of Weight Loss Diet and Pumpkin Seed Flour Consumption on Obese Women

March 12, 2014 updated by: Anna Paula Soares de Oliveira Carvalho, Universidade Federal do Rio de Janeiro

Effect of Hypoenergetic Diet Combined With Pumpkin Seed Flour Consumption on Obese Women

This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Federal University of Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age from 20 to 59 years old.
  • body mass index above 30 kg/m2

Exclusion Criteria:

  • diabetic
  • loss weight before the research
  • consumption of vitamins or dietary supplement.
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pumpkin seed flour
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
Dietary supplement: pumpkin seed flour
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
Placebo Comparator: Cassava flavored flour
The placebo group (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
Dietary supplement: Placebo (cassava flavored flour)
The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measures
Time Frame: Change from Baseline at 12 weeks
body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference
Change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: Change from baseline at 12 weeks
total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl)
Change from baseline at 12 weeks
Blood glucose
Time Frame: Change from baseline at 12 weeks
glucose (mg/dL)
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Study Director: Glorimar Rosa, Doctor, Universidade Federal do Rio de Janeiro
  • Study Chair: Gláucia MM Oliveira, Doctor, Universidade Federal do Rio de Janeiro
  • Principal Investigator: Anna SO Carvalho, Master, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACarvalho

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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