ObesityNCT01041261
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
A study testing BariatrX Essentials 360 Treatment in people with Obesity and Morbid Obesity, run by MetaProteomics LLC at 1 site in United States.
Trial summary
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- BariatrX Essentials 360 Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2012
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese and morbidly obese women (BMI 30 - 50)
- 25 years and older undergoing laparoscopic gastric bypass surgery
- Present with at least either metabolic syndrome or diabetes
Who cannot join
- Have smoked in the past 4 weeks
- Pregnant
- Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
- There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Pilot Study to Compare the Effects of a Novel Dietary Intervention With the Post-operative Standard of Care on Body Composition After Laparoscopic Gastric Bypass Surgery
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.
Read the detailed description
STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at Boston Medical Center, in obese women subjects undergoing Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also be provided as part of the study's protocol.
Subjects will be selected from surgical candidates of the Nutrition and Weight Management Center who meet the study criteria. Subjects will be randomly assigned to one of the 2 groups (treatment and control). Subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). Data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. Safety indicators and compliance will also be monitored.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- BariatrX Essentials 360 Treatment
- Keywords
- Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BariatrX Essentials 360 TreatmentDietary supplement
Also called BariatrX Essentials 360
Medical food
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added) |
| Treatment arm | Experimental | Medical food Receives: Dietary Supplement: BariatrX Essentials 360 Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and extracellular water (by cold bromide and deuterium method)
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Dual energy X-ray absorptiometry (DEXA)
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Secondary outcomes (6)
Hair loss (by photographic method and Hair-Scalp Questionnaire)
Measured: Baseline, 12 weeks, and 24 weeks
Impedance plethysmography (by distal and proximal electrode placement)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Muscle strength (by a handgrip dynamometer)
Measured: Baseline, 4weeks, 12 weeks, and 24 weeks
Resting energy expenditure (by indirect calorimetry)
Measured: Baseline, 4 weeks, 12 weeks and 24 weeks
Pulse after a 6-minute walk
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks
Measures of insulin resistance, visceral protein/nutritional status, and inflammation
Measured: Baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJan 2012
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetaProteomics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Caroline Apovian, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041261
- Sponsor's protocol ID
- BAR1-BMC-CT
- Status last verified
- Jan 2012
- First submitted
- 29 Dec 2009
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Pilot Study to Compare the Effects of a Novel Dietary Intervention With the Post-operative Standard of Care on Body Composition After Laparoscopic Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01041261
- Acronym / sponsor ID
- BAR1-BMC-CT
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MetaProteomics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Dec 2009 (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.
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.
Detailed description
STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at Boston Medical Center, in obese women subjects undergoing Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also be provided as part of the study's protocol.
Subjects will be selected from surgical candidates of the Nutrition and Weight Management Center who meet the study criteria. Subjects will be randomly assigned to one of the 2 groups (treatment and control). Subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). Data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. Safety indicators and compliance will also be monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added) |
| Treatment arm | Experimental | Dietary Supplement: BariatrX Essentials 360 TreatmentMedical food |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese and morbidly obese women (BMI 30 - 50)
- 25 years and older undergoing laparoscopic gastric bypass surgery
- Present with at least either metabolic syndrome or diabetes
Key exclusion criteria (4 listed)
- Have smoked in the past 4 weeks
- Pregnant
- Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
- There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study
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 |
|---|---|---|
| BariatrX Essentials 360 TreatmentAlso: BariatrX Essentials 360Medical food | Dietary supplement | Treatment arm |
Primary outcome
Total and extracellular water (by cold bromide and deuterium method)
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
6 secondary outcomes
Hair loss (by photographic method and Hair-Scalp Questionnaire)
Time frame: Baseline, 12 weeks, and 24 weeks
Impedance plethysmography (by distal and proximal electrode placement)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Muscle strength (by a handgrip dynamometer)
Time frame: Baseline, 4weeks, 12 weeks, and 24 weeks
Resting energy expenditure (by indirect calorimetry)
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
Pulse after a 6-minute walk
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks
Measures of insulin resistance, visceral protein/nutritional status, and inflammation
Time frame: Baseline, 12 weeks, and 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
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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.
Caroline Apovian, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BariatrX Essentials 360 Treatment in people with Obesity and Morbid Obesity, run by MetaProteomics LLC at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 13 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 United States. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Total and extracellular water (by cold bromide and deuterium method) (time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery). 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?
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 Jan 2012.