search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
pumpkin seed flour
Placebo (cassava flavored flour)
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, cardiovascular risk factors, pumpkin seed, diet quality

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pumpkin seed flour

Cassava flavored flour

Arm Description

The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks

The placebo group (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.

Outcomes

Primary Outcome Measures

Anthropometric measures
body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference

Secondary Outcome Measures

Blood lipids
total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl)
Blood glucose
glucose (mg/dL)

Full Information

First Posted
March 11, 2014
Last Updated
March 12, 2014
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
search

1. Study Identification

Unique Protocol Identification Number
NCT02086396
Brief Title
Effect of Weight Loss Diet and Pumpkin Seed Flour Consumption on Obese Women
Official Title
Effect of Hypoenergetic Diet Combined With Pumpkin Seed Flour Consumption on Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, cardiovascular risk factors, pumpkin seed, diet quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pumpkin seed flour
Arm Type
Experimental
Arm Description
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
Arm Title
Cassava flavored flour
Arm Type
Placebo Comparator
Arm Description
The placebo group (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
pumpkin seed flour
Intervention Description
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (cassava flavored flour)
Intervention Description
The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
Primary Outcome Measure Information:
Title
Anthropometric measures
Description
body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Blood lipids
Description
total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl)
Time Frame
Change from baseline at 12 weeks
Title
Blood glucose
Description
glucose (mg/dL)
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glorimar Rosa, Doctor
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gláucia MM Oliveira, Doctor
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna SO Carvalho, Master
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs