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The Influence of Probiotics on Body Weight and Composition (WLP)

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ClinicalTrials.gov Identifier: NCT02465294
Recruitment Status : Withdrawn (study withdrawn due to funding)
First Posted : June 8, 2015
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Overweight Dietary Supplement: Probiotic Behavioral: Behavioral lifestyle intervention Other: Placebo Other: Blood Test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Study Start Date : February 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Placebo Comparator: Potato starch and magnesium stearate
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.
Behavioral: Behavioral lifestyle intervention
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.

Other: Placebo
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.
Other Name: Potato starch and magnesium stearate

Other: Blood Test
All subjects will have blood tests performed.

Experimental: Lactobacillus
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.
Dietary Supplement: Probiotic
This group will receive the Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
Other Name: Lactobacillus

Behavioral: Behavioral lifestyle intervention
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.

Other: Blood Test
All subjects will have blood tests performed.

Experimental: Mix of Bifidobacterium and Lactobacillus
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.
Behavioral: Behavioral lifestyle intervention
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.

Other: Blood Test
All subjects will have blood tests performed.

Dietary Supplement: Probiotic
This group will receive the blend of Bifidobacterium and Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
Other Name: A blend of Bifidobacterium and Lactobacillus




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes in body composition (Fat mass) between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline to Week 12 ]
    Fat mass (kg)

  2. Changes in body composition (Waist circumference) between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline to Week 12 ]
    Waist circumference (cm)

  3. Changes in body composition (Sagittal abdominal diameter) between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline to Week 12 ]
    Sagittal abdominal diameter (cm)

  4. Changes in bowel habits between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline (Week -1) to Week 12 ]
    Bowel movement frequency (average number per week)

  5. Changes in gastrointestinal symptoms between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline (Week -1) to Week 12 ]
    Symptoms measured using the Gastrointestinal Symptom Rating Score questionnaire provide a score for the follow five syndromes: abdominal pain, reflux, constipation, diarrhea, and indigestion.

  6. Changes in markers of cardiovascular health between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline to Week 12 ]
    Serum cholesterol (mg/dl)

  7. Changes in nutritional intake between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline (Week -1) to Week 12 ]
    Total energy intake (kcal) will be assessed using the automated self-administered 24 hour dietary recall.

  8. Changes in weight control strategies between the probiotic groups and the placebo group [ Time Frame: Changes from Pre-baseline (Week -1) to Week 12 ]
    Differences in weight control strategies questionnaire scores

  9. 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 ]
    Stool samples will be collected from a subgroup of participants to analyze intestinal microbiota community composition.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465294


Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02465294     History of Changes
Other Study ID Numbers: IRB201400484
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Probiotics
Weight loss
Body composition

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms