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

Advanced Protein Technologies Corporation

Status

Completed

Conditions

Weight Loss

Treatments

Dietary Supplement: 2'-Fucosyllactose

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06547801

IRB2022-1559F

APT00001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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