NCT02086396

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 11, 2014

Last Update Submit

March 12, 2014

Conditions

Obesity

Keywords

obesitycardiovascular risk factorspumpkin seeddiet quality

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measures

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

    Change from Baseline at 12 weeks

Secondary Outcomes (2)

  • Blood lipids

    Change from baseline at 12 weeks

  • Blood glucose

    Change from baseline at 12 weeks

Study Arms (2)

pumpkin seed flour

EXPERIMENTAL

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

Dietary Supplement: pumpkin seed flour

Cassava flavored flour

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (cassava flavored flour)

Interventions

pumpkin seed flourDIETARY_SUPPLEMENT

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

pumpkin seed flour
Placebo (cassava flavored flour)DIETARY_SUPPLEMENT

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

Cassava flavored flour

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Glorimar Rosa, Doctor

    Universidade Federal do Rio de Janeiro

    STUDY DIRECTOR

  • Gláucia MM Oliveira, Doctor

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR

  • Anna SO Carvalho, Master

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters in Cardiovascular Sciences

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

September 1, 2013

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

BR(1)