ObesityNCT02086396
Effect of Weight Loss Diet and Pumpkin Seed Flour Consumption on Obese Women
A study testing pumpkin seed flour in people with Obesity, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- pumpkin seed flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age from 20 to 59 years old.
- body mass index above 30 kg/m2
Who cannot join
- diabetic
- loss weight before the research
- consumption of vitamins or dietary supplement.
- pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-913
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- pumpkin seed flour, Placebo (cassava flavored flour)
- Keywords
- obesity, cardiovascular risk factors, pumpkin seed, diet quality
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pumpkin seed flourDietary supplement
The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
Placebo (cassava flavored flour)Dietary supplement
The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| pumpkin seed flour | Experimental | The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks Receives: 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. Receives: Dietary Supplement: Placebo (cassava flavored flour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measures
body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference
Measured: Change from Baseline at 12 weeks
Secondary outcomes (2)
Blood lipids
total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl)
Measured: Change from baseline at 12 weeks
Blood glucose
glucose (mg/dL)
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Anna Paula Soares de Oliveira Carvalho, Universidade Federal do Rio de Janeiro
- Investigators
- Glorimar Rosa, Doctor, Study director, Universidade Federal do Rio de JaneiroGláucia MM Oliveira, Doctor, Study chair, Universidade Federal do Rio de JaneiroAnna SO Carvalho, Master, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086396
- Sponsor's protocol ID
- ACarvalho
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypoenergetic Diet Combined With Pumpkin Seed Flour Consumption on Obese Women
- ClinicalTrials.gov ID
- NCT02086396
- Acronym / sponsor ID
- ACarvalho
- Conditions
- Obesity
- Keywords
- obesity, cardiovascular risk factors, pumpkin seed, diet quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pumpkin seed flour | Experimental | Dietary Supplement: pumpkin seed flourThe pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks |
| Cassava flavored flour | Placebo comparator | Dietary Supplement: Placebo (cassava flavored flour)The placebo group (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age from 20 to 59 years old.
- body mass index above 30 kg/m2
Key exclusion criteria (4 listed)
- diabetic
- loss weight before the research
- consumption of vitamins or dietary supplement.
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pumpkin seed flourThe pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks | Dietary supplement | pumpkin seed flour |
| Placebo (cassava flavored flour)The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks. | Dietary supplement | Cassava flavored flour |
Primary outcome
Anthropometric measures
Time frame: Change from Baseline at 12 weeks
body weight (kg), body mass index (kg/m2), waist circumference (cm), neck circumference
2 secondary outcomes
Blood lipids
Time frame: Change from baseline at 12 weeks
Blood glucose
Time frame: Change from baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glorimar Rosa, Doctor study director
Universidade Federal do Rio de Janeiro
Gláucia MM Oliveira, Doctor study chair
Universidade Federal do Rio de Janeiro
Anna SO Carvalho, Master principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pumpkin seed flour in people with Obesity, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measures (time frame: Change from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.