effects of human milk oligosaccharide ingestion on weight loss and markers of health

Conditions: Weight Loss

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.

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.

Eligibility criteria:
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 (\ 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

Keywords: 2'-fucosyllactose inflammation functional capacity