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Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health

NCT06547801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-14

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

2'-Fucosyllactose

3 g/day of powder orally once daily

DIETARY_SUPPLEMENT

Maltodextrin

3 g/day of powder orally once daily

Sponsors & Collaborators

  • Advanced Protein Technologies Corporation

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2023-08-20
Completion
2024-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547801 on ClinicalTrials.gov