Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals

Overview

Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

Full Title of Study: “Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: June 2023

Detailed Description

This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.

Interventions

  • Dietary Supplement: Probiotic
    • Live bacteria strain in a form of a capsule with a daily dose of 1×10^10 CFU per day for 16 weeks
  • Dietary Supplement: Postbiotic
    • Heat treated bacteria strain in a form of a capsule with a daily dose of 1×10^10 CFU per day for 16 weeks
  • Other: Placebo
    • Placebo in a form of a capsule given for 16 weeks

Arms, Groups and Cohorts

  • Active Comparator: Probiotic
    • Live bacteria strain in a form of a capsule with a daily dose of 1×10^10 Colony Forming Unit (CFU) per day for 16 weeks
  • Active Comparator: Postbiotic
    • Heat treated bacteria strain in a form of a capsule with a daily dose of 1×10^10 CFU per day for 16 weeks
  • Placebo Comparator: Placebo
    • Placebo in a form of a capsule administered for 16 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in visceral fat area
    • Time Frame: From week 0 to Week 16
    • Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16

Secondary Measures

  • Change in body weight
    • Time Frame: Week 0, Week 12, Week 16
    • Body weight (kg) will be assessed at week 0, Week 12, Week 16
  • Change in waist circumference
    • Time Frame: Week 0, Week 12, Week 16
    • Change in waist circumference (cm) at week 0, week 12 and week 16
  • Change in body fat composition
    • Time Frame: Week 0, Week 12, Week 16
    • Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16
  • Change in peripheral blood cholesterol
    • Time Frame: Week 0, Week 16
    • Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16
  • Change in serum insulin concentration
    • Time Frame: Week 0, Week 16
    • Change in serum insulin from week 0 to week 16
  • Change in peripheral blood glucose
    • Time Frame: Week 0, Week 16
    • Change in blood glucose from week 0 to week 16
  • Change in plasma leptin levels
    • Time Frame: Week 0, Week 16
    • Change in leptin week 0 to week 16
  • Dietary survey
    • Time Frame: Week 0, Week 16
    • Food cravings will be assessed using the Food Craving Questionnaires (FCQ) at week 0 and week 16. The change in score compared to baseline and between groups will be assessed at the end of the study.
  • Microbiome analysis
    • Time Frame: Week 0, Week 16
    • Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing
  • Mood questionnaire
    • Time Frame: Week 0, Week 16
    • Participants mood will be assessed using the PHQ-9 (Patient Health Questionnaire-9). The change in score compared to baseline and between groups will be assessed at the end of the study.

Participating in This Clinical Trial

Inclusion Criteria

  • Body mass index 25-33kg/m2 – Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm) – written informed consent Exclusion Criteria:

  • Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive – taking antibiotics within 2 months before starting the study – secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension – consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit – nicotine, drug or alcohol abuse, – other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Archer-Daniels-Midland Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel Ramon Vidal, Study Chair, ADM Biopolis
  • Overall Contact(s)
    • Vineetha Vijayakumar, PhD, 07885966211, vineetha.vijayakumar@adm.com

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