NCT02151825

Brief Summary

The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 28, 2014

Last Update Submit

May 28, 2014

Conditions

Gut MicrobiotaAdiposity

Keywords

Gut microbiotaProbioticsPrebioticsSynbioticBifidobacterium lactis BB-12Lactobacillus acidophilus LA-5Lactobacillus casei 431InulinGOSBody WeightOverweightAdiposityObesityANGPTL4

Outcome Measures

Primary Outcomes (1)

  • Changes to the gut microbiota

    The primary objective of this study is to determine the effect of a synbiotic formulation called ProSynbiotic (administered at 3 capsules/day) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota of healthy overweight adult subjects when compared to a placebo of maltodextrin. Changes in the gut microbiota will be determined by measuring specific bacterial population levels in the subjects' fecal samples, using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation.

    0-weeks (Baseline), 6-weeks (midpoint of intervention), 12-weeks (end of intervention) and 16-weeks (4-weeks after end of intervention)

Secondary Outcomes (3)

  • Body composition

    Baseline, 6-weeks and 12-weeks.

  • Expression of genes mediating dietary energy harvest and adiposity

    Baseline and 12-weeks

  • Adiposity-related metabolic markers

    Baseline and 12-weeks

Study Arms (2)

Synbiotic

EXPERIMENTAL

3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

3 capsules of Maltodextrin per day

Other: Placebo

Interventions

SynbioticDIETARY_SUPPLEMENT

3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)

Also known as: Prosynbiotic
Synbiotic
PlaceboOTHER

3 capsules of Maltodextrin per day

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-64
  • BMI of 25-34.9 and/or a waist circumference \>35 inches for women and \>40 inches for men
  • Generally healthy except for overweight or moderately obese
  • A signed consent form
  • Passed a screening questionnaire and willingness to comply with study procedures
  • Lipid levels, fasting glucose, liver function and complete blood counts within the normal reference ranges as measured in a screening blood sample

You may not qualify if:

  • Persons on a weight-loss regimen
  • Antibiotic use (\< 3 months before the study)
  • Regular probiotic, prebiotic or synbiotic use (\< 1 month before the study)
  • Regular use of anti-inflammatory drugs, weight-loss medications or supplements (\< 1 month prior to the study)
  • Personal history of cardiovascular disease, hypertension, cancer, type 1 or type 2 diabetes and inflammatory gastrointestinal disorders such as Crohn's disease or colitis
  • Smoking
  • Consumption of \>2 units of alcohol per day
  • Pregnancy or lactation
  • Irregular periods, menopause or hormone replacement therapy
  • Over 300 minutes of exercise per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

MeSH Terms

Conditions

ObesityBody WeightOverweight

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • Vatsala Maitin, PhD

    Texas State University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

US(1)