HealthyWLPNCT02465294
The Influence of Probiotics on Body Weight and Composition
A study testing Probiotic, Behavioral lifestyle intervention and Blood Test in people with Healthy and Overweight, run by University of Florida.
Trial summary
The purpose of this study is to evaluate the addition of two different probiotic interventions to a comprehensive behavioral lifestyle intervention on body weight loss and overall health in overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- Probiotic, Behavioral lifestyle intervention and Blood Test
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2016
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To participate in the study you must:
- Be age 18 to 75 years
- Have a BMI ≥ 25
- Be willing to receive random assignment to probiotic or placebo supplementation
- Be willing to and able to complete the Informed Consent Form in English
- Be willing to complete questionnaires, records, and diaries associated with the study and to complete all study visits
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- Be committed to losing weight over the 12-week study period
- Be willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
- Be willing to provide a social security number (SS#) to receive study payment? Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
Who cannot join
- To participate in the study you must NOT:
- Have used another investigational product within 3 months of enrolling in the study
- Be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months
- Be allergic to milk, soy, or yeast
- Have gained or lost at least 10 lbs in the previous 3 months
- Have had uncontrolled angina (severe chest pain) within the past 6 months
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- Have insulin-dependent diabetes (oral medications are not exclusionary)
- Use weight-loss medications
- Have had cancer treatment (radiation, chemotherapy, or surgery) within the past 6 months or any other treatment or condition known to weaken the immune system (e.g., systemic corticosteroids or HIV/AIDS)
- Be currently being treated for or have any of the following physician-diagnosed diseases or conditions: inflammatory bowel disease, celiac disease, short bowel syndrome, or any other malabsorptive syndrome?
- Have any physical condition deemed likely to significantly interfere with your ability to participate in a lifestyle intervention involving eating and physical activity changes
- Be currently participating in Weight Watcher's or another weight loss program
About this study
Official title: The Influence of Probiotics With a Behavioral Life Style Intervention on Body Weight and Composition in Overweight Participants: A Randomized, Double-blinded, Placebo-controlled Study.
The purpose of this study is to evaluate the addition of two different probiotic interventions to a comprehensive behavioral lifestyle intervention on body weight loss and overall health in overweight adults.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled study. After obtaining informed consent, healthy overweight adults aged 18 to 75 years (n=76/intervention group with n=228 total/study) will be randomized to one of three groups: Lactobacillus, a blend of Bifidobacterium and Lactobacillus, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 12 weeks. Participants will attend weekly behavioral lifestyle intervention meetings, which will address dietary and physical activity contributions to weight loss, in groups of approximately 20 subjects during the 12 intervention weeks.
Participants will complete daily questionnaires throughout the week before and during the intervention period which address subject compliance and bowel habits. A dual X-ray absorptivity scan will be done to measure body composition during the week before the intervention and during the 12th week of the intervention period (± 1 week). Blood samples will be collected via a finger prick at the baseline and final time points. Blood samples will be used to measure cardiovascular and metabolic markers of health. Stool samples will be collected from 25 subjects per intervention group during the week before the intervention period and the 12th week of the intervention period. Dietary intake will be assessed during the week before the intervention period and during the week of the final appointment (± 1 week). Gastrointestinal symptoms and physical activity questionnaires will be completed upon providing consent to the study, being randomized to an intervention, and during the last week of the intervention period. Questionnaires regarding income, weight control strategies, and quality of life will be completed during randomization and during the last week of the intervention period. Stool samples will be collected from a subgroup of participants during the week before the intervention period and during the 12th week of the intervention period. These samples will be used to detect the presence and/or abundance and/or survival of the probiotic microorganisms at the end of the digestive tract.
- Conditions
- Healthy, Overweight
- Being tested
- Probiotic, Behavioral lifestyle intervention, Placebo, Blood Test
- Keywords
- Probiotics, Weight loss, Body composition
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Lactobacillus
This group will receive the Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
Behavioral lifestyle interventionBehavioural
All participants will participate in weekly group meetings of 15 to 20 participants for a facilitated discussion of specific nutritional, behavioral, and physical activity topics chosen to promote weight loss.
PlaceboOther
Also called Potato starch and magnesium stearate
This group will receive the placebo and will be taken as a capsule once daily for 12 weeks. The placebo will contain encapsulated potato starch which is used the matrix in the probiotic supplements.
Blood TestOther
All subjects will have blood tests performed.
ProbioticDietary supplement
Also called A blend of Bifidobacterium and Lactobacillus
This group will receive the blend of Bifidobacterium and Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Potato starch and magnesium stearate | Placebo comparator | This arm will be used as a control to asses the efficacy of the other probiotic arms. The placebo will contain encapsulated potato starch and magnesium stearate which is used the matrix in the probiotic supplements. The placebo refers only to the intervention supplement, not the behavioral lifestyle intervention. All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. Receives: Behavioral: Behavioral lifestyle intervention; Other: Placebo; Other: Blood Test |
| Lactobacillus | Experimental | Lactobacillus will be taken as a capsule once daily for 12 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. Receives: Dietary Supplement: Probiotic; Behavioral: Behavioral lifestyle intervention; Other: Blood Test |
| Mix of Bifidobacterium and Lactobacillus | Experimental | A blend of Bifidobacterium and Lactobacillus will be taken as a capsule once daily for 12 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. Receives: Behavioral: Behavioral lifestyle intervention; Other: Blood Test; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in baseline to week 12 in the percentage of body weight lost between the probiotic groups and the placebo group
Body weight (kg)
Measured: Change from Baseline (start of week 1) to Week 12
Secondary outcomes (9)
Changes in body composition (Fat mass) between the probiotic groups and the placebo group
Fat mass (kg)
Measured: Changes from Pre-baseline to Week 12
Changes in body composition (Waist circumference) between the probiotic groups and the placebo group
Waist circumference (cm)
Measured: Changes from Pre-baseline to Week 12
Changes in body composition (Sagittal abdominal diameter) between the probiotic groups and the placebo group
Sagittal abdominal diameter (cm)
Measured: Changes from Pre-baseline to Week 12
Changes in bowel habits between the probiotic groups and the placebo group
Bowel movement frequency (average number per week)
Measured: Changes from Pre-baseline (Week -1) to Week 12
Changes in gastrointestinal symptoms between the probiotic groups and the placebo group
Symptoms measured using the Gastrointestinal Symptom Rating Score questionnaire provide a score for the follow five syndromes: abdominal pain, reflux, constipation, diarrhea, and indigestion.
Measured: Changes from Pre-baseline (Week -1) to Week 12
Changes in markers of cardiovascular health between the probiotic groups and the placebo group
Serum cholesterol (mg/dl)
Measured: Changes from Pre-baseline to Week 12
Changes in nutritional intake between the probiotic groups and the placebo group
Total energy intake (kcal) will be assessed using the automated self-administered 24 hour dietary recall.
Measured: Changes from Pre-baseline (Week -1) to Week 12
Changes in weight control strategies between the probiotic groups and the placebo group
Differences in weight control strategies questionnaire scores
Measured: Changes from Pre-baseline (Week -1) to Week 12
Changes in intestinal microbiota community composition between the probiotic groups and the placebo group
Stool samples will be collected from a subgroup of participants to analyze intestinal microbiota community composition.
Measured: Changes from Pre-baseline (Week -1) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: study withdrawn due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465294
- Sponsor's protocol ID
- IRB201400484
- Acronym
- WLP
- Status last verified
- Feb 2016
- First submitted
- 1 Jun 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Probiotics With a Behavioral Life Style Intervention on Body Weight and Composition in Overweight Participants: A Randomized, Double-blinded, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT02465294
- Acronym / sponsor ID
- WLP / IRB201400484
- Conditions
- Healthy, Overweight
- Keywords
- Probiotics, Weight loss, Body composition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn due to funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jun 2015 (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 purpose of this study is to evaluate the addition of two different probiotic interventions to a comprehensive behavioral lifestyle intervention on body weight loss and overall health in overweight adults.
Detailed description
This is a randomized, double-blinded, placebo-controlled study. After obtaining informed consent, healthy overweight adults aged 18 to 75 years (n=76/intervention group with n=228 total/study) will be randomized to one of three groups: Lactobacillus, a blend of Bifidobacterium and Lactobacillus, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 12 weeks. Participants will attend weekly behavioral lifestyle intervention meetings, which will address dietary and physical activity contributions to weight loss, in groups of approximately 20 subjects during the 12 intervention weeks.
Participants will complete daily questionnaires throughout the week before and during the intervention period which address subject compliance and bowel habits. A dual X-ray absorptivity scan will be done to measure body composition during the week before the intervention and during the 12th week of the intervention period (± 1 week). Blood samples will be collected via a finger prick at the baseline and final time points. Blood samples will be used to measure cardiovascular and metabolic markers of health. Stool samples will be collected from 25 subjects per intervention group during the week before the intervention period and the 12th week of the intervention period. Dietary intake will be assessed during the week before the intervention period and during the week of the final appointment (± 1 week). Gastrointestinal symptoms and physical activity questionnaires will be completed upon providing consent to the study, being randomized to an intervention, and during the last week of the intervention period. Questionnaires regarding income, weight control strategies, and quality of life will be completed during randomization and during the last week of the intervention period. Stool samples will be collected from a subgroup of participants during the week before the intervention period and during the 12th week of the intervention period. These samples will be used to detect the presence and/or abundance and/or survival of the probiotic microorganisms at the end of the digestive tract.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Potato starch and magnesium stearate | Placebo comparator | Behavioral: Behavioral lifestyle intervention, Other: Placebo, Other: Blood TestThis arm will be used as a control to asses the efficacy of the other probiotic arms. The placebo will contain encapsulated potato starch and magnesium stearate which is used the matrix in the probiotic supplements. The placebo refers only to the intervention supplement, not the behavioral lifestyle intervention. All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. |
| Lactobacillus | Experimental | Dietary Supplement: Probiotic, Behavioral: Behavioral lifestyle intervention, Other: Blood TestLactobacillus will be taken as a capsule once daily for 12 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. |
| Mix of Bifidobacterium and Lactobacillus | Experimental | Behavioral: Behavioral lifestyle intervention, Other: Blood Test, Dietary Supplement: ProbioticA blend of Bifidobacterium and Lactobacillus will be taken as a capsule once daily for 12 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). All subjects will participate in the same behavioral lifestyle intervention. In addition, blood tests will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be age 18 to 75 years
- Have a BMI ≥ 25
- Be willing to receive random assignment to probiotic or placebo supplementation
- Be willing to and able to complete the Informed Consent Form in English
- Be willing to complete questionnaires, records, and diaries associated with the study and to complete all study visits
Key exclusion criteria (12 listed)
- Have used another investigational product within 3 months of enrolling in the study
- Be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months
- Be allergic to milk, soy, or yeast
- Have gained or lost at least 10 lbs in the previous 3 months
- Have had uncontrolled angina (severe chest pain) within the past 6 months
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 |
|---|---|---|
| ProbioticAlso: LactobacillusThis group will receive the Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks. | Dietary supplement | Lactobacillus |
| Behavioral lifestyle interventionAll participants will participate in weekly group meetings of 15 to 20 participants for a facilitated discussion of specific nutritional, behavioral, and physical activity topics chosen to promote weight loss. | Behavioural | Lactobacillus, Mix of Bifidobacterium and Lactobacillus, Potato starch and magnesium stearate |
| PlaceboAlso: Potato starch and magnesium stearateThis group will receive the placebo and will be taken as a capsule once daily for 12 weeks. The placebo will contain encapsulated potato starch which is used the matrix in the probiotic supplements. | Other | Potato starch and magnesium stearate |
| Blood TestAll subjects will have blood tests performed. | Other | Lactobacillus, Mix of Bifidobacterium and Lactobacillus, Potato starch and magnesium stearate |
| ProbioticAlso: A blend of Bifidobacterium and LactobacillusThis group will receive the blend of Bifidobacterium and Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks. | Dietary supplement | Mix of Bifidobacterium and Lactobacillus |
Primary outcome
Changes in baseline to week 12 in the percentage of body weight lost between the probiotic groups and the placebo group
Time frame: Change from Baseline (start of week 1) to Week 12
Body weight (kg)
9 secondary outcomes
Changes in body composition (Fat mass) between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline to Week 12
Changes in body composition (Waist circumference) between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline to Week 12
Changes in body composition (Sagittal abdominal diameter) between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline to Week 12
Changes in bowel habits between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline (Week -1) to Week 12
Changes in gastrointestinal symptoms between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline (Week -1) to Week 12
Changes in markers of cardiovascular health between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline to Week 12
Changes in nutritional intake between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline (Week -1) to Week 12
Changes in weight control strategies between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline (Week -1) to Week 12
Changes in intestinal microbiota community composition between the probiotic groups and the placebo group
Time frame: Changes from Pre-baseline (Week -1) to Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Bobbi Langkamp-Henken, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Behavioral lifestyle intervention and Blood Test in people with Healthy and Overweight, run by University of Florida.
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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in baseline to week 12 in the percentage of body weight lost between the probiotic groups and the placebo group (time frame: Change from Baseline (start of week 1) to Week 12). 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 9 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.