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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
60
3 g/day of powder orally once daily
3 g/day of powder orally once daily
Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station
College Station, Texas, United States
Change in Body Weight
Change in body weight (kilograms) using a calibrated digital scale
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Body Height
Change in height (meters) using a calibrated digital scale
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Body Mass Index (BMI)
Body Mass Index (BMI) calculated using weight and height, expressed in kg/m².
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Fat Mass
Change in fat mass (kilograms) measured using a calibrated Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Lean Body Mass
Lean body mass (kilograms) calculated using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Body Fat
Body fat percentage calculated using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Bone Mineral Content
Bone mineral content (grams) measured using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Waist Circumference
Waist circumference (centimeters) measured with a soft tape.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Hip Circumference
Hip circumference (centimeters) measured with a soft tape.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Aerobic Capacity
Change in peak oxygen uptake (L/min) from baseline.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in White Blood cell
White Blood cells (K/uL) were analyzed from collected fasting whole blood samples.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Red Blood cell
Red Blood cells (M/uL) were analyzed from collected fasting whole blood samples.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Hemoglobin
Hemoglobins (g/dL) were analyzed from collected fasting whole blood samples.
Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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