ObesityPhase 2NCT01505023
Partial Meal Replacement and Inulin in Obese Women
A Phase 2 study testing Partial meal replacement, Partial meal replacement with inulin and Inulin in people with Obesity, run by Cindetec at 1 site in Mexico.
Trial summary
The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Partial meal replacement, Partial meal replacement with inulin and Inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2006to Feb 2007
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- Adult
Who may be able to join
- BMI > 25 kg/m 2
Who cannot join
- Pregnant
- Lactating
- Diagnosed with diabetes
- Diagnosed with hypertension
- Fasting glucose ≥126 mg/dL
- Blood triglycerides ≥400mg/dL
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de Querétaro
Querétaro City, Querétaro, 76230
About this study
Official title: Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women
- Conditions
- Obesity
- Being tested
- Partial meal replacement, Partial meal replacement with inulin, Inulin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial meal replacementDietary supplement
The PMR was designed to contain sufficient amounts of all vitamins and minerals. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
Partial meal replacement with inulinDietary supplement
The PMR was designed to contain sufficient amounts of all vitamins and minerals plus inulin. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
InulinDietary supplement
Women were asked to consume one 5g serving of inulin mixed with any drink at breakfast and same amount at dinner (10 g of inulin/d).
| Study group | Role | What they receive |
|---|---|---|
| Partial meal replacement | Active comparator | Not described Receives: Dietary Supplement: Partial meal replacement |
| Partial meal replacement with inulin | Experimental | Not described Receives: Dietary Supplement: Partial meal replacement with inulin |
| Inulin | Active comparator | Not described Receives: Dietary Supplement: Inulin |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Blood lipids
Secondary outcomes (1)
Micronutrients intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startApr 2006
- Primary completionNov 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cindetec
- Sponsor type
- University, hospital or other
- Collaborators
- Nucitec SA de CV
- Responsible party
- Principal investigator, SANDRA GARCiA PADILLA, Cindetec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505023
- Sponsor's protocol ID
- PEE-001-2004
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tovar AR, Caamano Mdel C, Garcia-Padilla S, Garcia OP, Duarte MA, Rosado JL. The inclusion of a partial meal replacement with or without inulin to a calorie restricted diet contributes to reach recommended intakes of micronutrients and decrease plasma triglycerides: a randomized clinical trial in obese Mexican women. Nutr J. 2012 Jun 18;11:44. doi: 10.1186/1475-2891-11-44.
PubMed 22703579
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
- ClinicalTrials.gov ID
- NCT01505023
- Acronym / sponsor ID
- PEE-001-2004
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- CindetecUniversity, hospital or other
- Collaborators
- Nucitec SA de CV
- Study start
- Apr 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 6 Jan 2012 (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.
The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Partial meal replacement | Active comparator | Dietary Supplement: Partial meal replacement |
| Partial meal replacement with inulin | Experimental | Dietary Supplement: Partial meal replacement with inulin |
| Inulin | Active comparator | Dietary Supplement: Inulin |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI > 25 kg/m 2
Key exclusion criteria (6 listed)
- Pregnant
- Lactating
- Diagnosed with diabetes
- Diagnosed with hypertension
- Fasting glucose ≥126 mg/dL
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 |
|---|---|---|
| Partial meal replacementThe PMR was designed to contain sufficient amounts of all vitamins and minerals. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk. | Dietary supplement | Partial meal replacement |
| Partial meal replacement with inulinThe PMR was designed to contain sufficient amounts of all vitamins and minerals plus inulin. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk. | Dietary supplement | Partial meal replacement with inulin |
| InulinWomen were asked to consume one 5g serving of inulin mixed with any drink at breakfast and same amount at dinner (10 g of inulin/d). | Dietary supplement | Inulin |
Primary outcome
Weight
Blood lipids
1 secondary outcome
Micronutrients intake
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 6 Jan 2012.
- Derived from this study: PubMed 22703579Tovar AR, Caamano Mdel C, Garcia-Padilla S, Garcia OP, Duarte MA, Rosado JL. The inclusion of a partial meal replacement with or without inulin to a calorie restricted diet contributes to reach recommended intakes of micronutrients and decrease plasma triglycerides: a randomized clinical trial in obese Mexican women. Nutr J. 2012 Jun 18;11:44. doi: 10.1186/1475-2891-11-44.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partial meal replacement, Partial meal replacement with inulin and Inulin in people with Obesity, run by Cindetec at 1 site in Mexico.
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 1 inclusion and 6 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 6 Jan 2012. 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505023, which also lists 1 linked publication.
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 6 Jan 2012; AzTrials last refreshed its copy on 6 Nov 2026.