Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
NCT Number: NCT06547801
Acronym: HMO-RCT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight Loss
Interventions: DIETARY_SUPPLEMENT: 2'-Fucosyllactose|DIETARY_SUPPLEMENT: Maltodextrin
Sponsor: Advanced Protein Technologies Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-05-04
Completion Date: 2024-02-22
Locations: Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station, College Station, Texas, 77843, United States

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.

Primary Outcome Measures: Change in Body Weight, Change in body weight (kilograms) using a calibrated digital scale, baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)|Change in Body Height, Change in height (meters) using a calibrated digital scale, 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., 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)., 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)., 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)., 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)., baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)|Change in Waist Circumference, Waist circumference (centimeters) measured with a soft tape., baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)|Change in Hip Circumference, Hip circumference (centimeters) measured with a soft tape., baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Secondary Outcome Measures: Change in Aerobic Capacity, Change in peak oxygen uptake (L/min) from baseline., 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., 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., baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)|Change in Hemoglobin, Hemoglobins (g/dL) were analyzed from collected fasting whole blood samples., baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)