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Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health (HMO-RCT Trial)

N/A
Waitlist Available
Research Sponsored by Advanced Protein Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

Summary

A randomized, double-blind, placebo-controlled, parallel arm study of 2'-fucosyllactose (2'-FL) was conducted in healthy males and females between the ages of 18 and 65 at the time of consent. 2'-FL is one of the most prominent HMOs in human milk. Preclinical studies indicate that 2'-FL feeding is prebiotic, anti-inflammatory, anti-thrombotic, and may reduce skeletal muscle atrophy during energy restriction. The investigators hypothesize that supplementation of 2'-FL affects the preservation of muscle mass, strength, and markers of health during exercise and a hypo-energetic weight loss program. To test this hypothesis, the investigators will compare 3 g/day of 2'-FL with 3 g/day of maltodextrin placebo as a daily supplement.

Eligible Conditions
  • Obesity
  • Weight Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Body Fat
Change in Body Height
Change in Body Mass Index (BMI)
+6 more
Secondary study objectives
Change in Aerobic Capacity
Change in Hemoglobin
Change in Red Blood cell
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2'-fucosyllactoseExperimental Treatment1 Intervention
3 g/day of 2'-FL powder orally once daily for 12 weeks
Group II: MaltodextrinPlacebo Group1 Intervention
3 g/day of banana-flavored maltodextrin powder orally once daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
2'-Fucosyllactose
2023
N/A
~60

Find a Location

Who is running the clinical trial?

Advanced Protein Technologies CorporationLead Sponsor
Richard B Kreider, ProfessorStudy Directorrbkreider@tamu.edu
~23 spots leftby Dec 2025
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