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Completed

NCT Number: NCT06547801

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station

College Station, Texas, 77843, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2'-Fucosyllactose

Dietary Supplement

3 g/day of powder orally once daily

Maltodextrin

Dietary Supplement

3 g/day of powder orally once daily

Primary outcomes

  1. Change in Body Weight

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Change in body weight (kilograms) using a calibrated digital scale

  2. Change in Body Height

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Change in height (meters) using a calibrated digital scale

  3. Change in Body Mass Index (BMI)

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Body Mass Index (BMI) calculated using weight and height, expressed in kg/m².

  4. Change in Fat Mass

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    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).

  5. Change in Lean Body Mass

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Lean body mass (kilograms) calculated using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).

  6. Change in Body Fat

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Body fat percentage calculated using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).

  7. Change in Bone Mineral Content

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Bone mineral content (grams) measured using Hologic Discovery W (Hologic Inc., Waltham, MA, USA) with APEX Software (APEX Corporation, Pittsburgh, PA, USA).

  8. Change in Waist Circumference

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Waist circumference (centimeters) measured with a soft tape.

  9. Change in Hip Circumference

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Hip circumference (centimeters) measured with a soft tape.

Secondary outcomes

  1. Change in Aerobic Capacity

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Change in peak oxygen uptake (L/min) from baseline.

  2. Change in White Blood cell

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    White Blood cells (K/uL) were analyzed from collected fasting whole blood samples.

  3. Change in Red Blood cell

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Red Blood cells (M/uL) were analyzed from collected fasting whole blood samples.

  4. Change in Hemoglobin

    Time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

    Hemoglobins (g/dL) were analyzed from collected fasting whole blood samples.

Sponsors and collaborators

Lead sponsor

Advanced Protein Technologies Corporation

Industry

Registry information

Acronym: HMO-RCT

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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