NCT06547801

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Advanced Protein Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objective: To investigate the effects of daily supplementation with 3 g/day of 2'-fucosyllactose (2'-FL) compared to 3 g/day of maltodextrin placebo on muscle mass preservation, strength, and health markers during exercise and a hypo-energetic weight loss program in healthy adults. Study Design: This study will be a randomized, double-blind, placebo-controlled, parallel arm trial. Participants: Participants will include healthy males and females aged 18 to 65 years at the time of consent, with a BMI between 25 to 40 kg/m² and/or body fat greater than 30%. Preference will be given to individuals with a BMI between 25 to 32 kg/m² who express a desire to lose weight and participate in a fitness exercise program. Intervention: Participants will be randomly assigned to receive either 3 g/day of 2'-FL or 3 g/day of maltodextrin placebo, administered daily for the duration of the study. Ethical Considerations: This study will adhere to ethical guidelines for human research, ensuring participant confidentiality, informed consent, and data protection. Timeline: The study will commence upon institutional approval and is expected to be completed within 12 weeks. This study aims to provide insights into the potential benefits of 2'-FL supplementation on muscle preservation, strength, and overall health during exercise and weight loss efforts, contributing to the understanding of its role as a dietary supplement.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	2'-Fucosyllactose	3 g/day of powder orally once daily
DIETARY_SUPPLEMENT	Maltodextrin	3 g/day of powder orally once daily

Timeline

• Start date: 2023-05-04
• Primary completion: 2023-08-20
• Completion: 2024-02-22
• First posted: 2024-08-09
• Last updated: 2024-08-14

Locations

1 site across 1 country: United States