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

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

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.

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.

Inclusion Criteria:

• Men and women the ages of 18 to 65 at the time of consent
• Ability to comply with study procedures
• Availability to complete the study based on duration of individual visits and scheduling requirements
• Body mass index (BMI) between 25 and 40 kg/m2 and/or body fat less than 30%, with a preference between a BMI of 25 - 32 kg/m2, and a desire to lose weight and participate in a fitness exercise program

Exclusion Criteria:

• Pregnant, breastfeeding, or wish to become pregnant during the study
• Planning major changes in lifestyle (i.e., diet, dieting, exercise level, travel) during the study
• Recent history (< 3 months) of exercise training or weight loss (> 5%)
• Orthopedic limitation preventing participation in a general fitness program
• Uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder in which participation in a general fitness program is contraindicated
• Taking weight loss dietary supplements or medications during the last 4 weeks
• History within the previous 12 months of alcohol or substance abuse
• Heavy smoking (> 1 pack/day within the past 3 months)
• Known allergy to milk, lactose, or any other milk product