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

August 12, 2024 updated by: Advanced Protein Technologies Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77843
        • Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2'-fucosyllactose
3 g/day of 2'-FL powder orally once daily for 12 weeks
Dietary supplement: 2'-Fucosyllactose
3 g/day of powder orally once daily
Placebo Comparator: Maltodextrin
3 g/day of banana-flavored maltodextrin powder orally once daily for 12 weeks
Dietary supplement: Maltodextrin
3 g/day of powder orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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).
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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).
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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).
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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).
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Waist Circumference
Time Frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Waist circumference (centimeters) measured with a soft tape.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in Hip Circumference
Time Frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Hip circumference (centimeters) measured with a soft tape.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
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.
baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Protein Technologies Corporation

Investigators

  • Study Director: Richard B Kreider, Professor, rbkreider@tamu.edu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2022-1559F
  • APT00001 (Other Grant/Funding Number: Advanced Protein Technologies Corp.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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