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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086396
• Other study ID #: ACarvalho
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: March 12, 2014
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• pumpkin seed flour
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
• Placebo (cassava flavored flour)
The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric measures	body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference	Change from Baseline at 12 weeks	Yes
Secondary	Blood lipids	total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl)	Change from baseline at 12 weeks	Yes
Secondary	Blood glucose	glucose (mg/dL)	Change from baseline at 12 weeks	Yes