NCT02465294

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

June 1, 2015

Last Update Submit

February 8, 2016

Conditions

HealthyOverweight

Keywords

ProbioticsWeight lossBody composition

Outcome Measures

Primary Outcomes (1)

  • Changes in baseline to week 12 in the percentage of body weight lost between the probiotic groups and the placebo group

    Body weight (kg)

    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

    Changes from Pre-baseline to Week 12

  • Changes in body composition (Waist circumference) between the probiotic groups and the placebo group

    Changes from Pre-baseline to Week 12

  • Changes in body composition (Sagittal abdominal diameter) between the probiotic groups and the placebo group

    Changes from Pre-baseline to Week 12

  • Changes in bowel habits between the probiotic groups and the placebo group

    Changes from Pre-baseline (Week -1) to Week 12

  • Changes in gastrointestinal symptoms between the probiotic groups and the placebo group

    Changes from Pre-baseline (Week -1) to Week 12

  • +4 more secondary outcomes

Study Arms (3)

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.

Behavioral: Behavioral lifestyle interventionOther: PlaceboOther: 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.

Dietary Supplement: ProbioticBehavioral: Behavioral lifestyle interventionOther: 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.

Behavioral: Behavioral lifestyle interventionOther: Blood TestDietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

This group will receive the Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.

Also known as: Lactobacillus
Lactobacillus
Behavioral lifestyle interventionBEHAVIORAL

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.

LactobacillusMix of Bifidobacterium and LactobacillusPotato starch and magnesium stearate
PlaceboOTHER

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.

Also known as: Potato starch and magnesium stearate
Potato starch and magnesium stearate
Blood TestOTHER

All subjects will have blood tests performed.

LactobacillusMix of Bifidobacterium and LactobacillusPotato starch and magnesium stearate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightWeight Loss

Interventions

ProbioticsLacteolstearic acidHematologic Tests

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Bobbi Langkamp-Henken, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share