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Weight LossHMO-RCTNCT06547801

Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health

A study testing 2'-Fucosyllactose and Maltodextrin in people with Weight Loss, run by Advanced Protein Technologies Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
2'-Fucosyllactose and Maltodextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
4 May 2023to 22 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    College Station, Texas, 77843

Other trials in United States

About this study

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.

Read the 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.

Conditions
Weight Loss
Being tested
2'-Fucosyllactose, Maltodextrin
Keywords
2'-Fucosyllactose, Inflammation, Functional capacity
Medical subject headings
Weight Loss, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2'-FucosyllactoseDietary supplement

    3 g/day of powder orally once daily

  • MaltodextrinDietary supplement

    3 g/day of powder orally once daily

Study groups in NCT06547801
Study groupRoleWhat they receive
2'-fucosyllactoseExperimental3 g/day of 2'-FL powder orally once daily for 12 weeks
Receives: Dietary Supplement: 2'-Fucosyllactose
MaltodextrinPlacebo comparator3 g/day of banana-flavored maltodextrin powder orally once daily for 12 weeks
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight

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

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

  2. Change in Body Height

    Change in height (meters) using a calibrated digital scale

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

  3. Change in Body Mass Index (BMI)

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

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

  4. 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).

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. Change in Waist Circumference

    Waist circumference (centimeters) measured with a soft tape.

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

  9. Change in Hip Circumference

    Hip circumference (centimeters) measured with a soft tape.

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

Secondary outcomes (4)

  1. Change in Aerobic Capacity

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

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

  2. Change in White Blood cell

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

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

  3. Change in Red Blood cell

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

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

  4. Change in Hemoglobin

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start4 May 2023
  3. Primary completion20 Aug 2023
  4. Study completion22 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study was conducted as a randomized, double-blind, placebo-controlled, parallel arm study. The Human Protection Institutional Review Board (IRB2022-1559F) approved the study following ethical standards for the conduct of human participant research as described in the Declaration of Helsinki.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547801
Sponsor's protocol ID
IRB2022-1559F
Other IDs
APT00001
Acronym
HMO-RCT
Status last verified
Aug 2024
First submitted
11 Jun 2024
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pak ME, Kim YJ, Kim H, Shin CS, Yoon JW, Jeon SM, Song YH, Kim K. Anti-Neuroinflammatory Effects of the Human Milk Oligosaccharide, 2'-Fucosyllactose, Exerted via Modulation of M2 Microglial Activation in a Mouse Model of Ischemia-Reperfusion Injury. Antioxidants (Basel). 2023 Jun 15;12(6):1281. doi: 10.3390/antiox12061281.

    PubMed 37372011

  • Le Huerou-Luron I, Blat S, Boudry G. Breast- v. formula-feeding: impacts on the digestive tract and immediate and long-term health effects. Nutr Res Rev. 2010 Jun;23(1):23-36. doi: 10.1017/S0954422410000065. Epub 2010 May 10.

    PubMed 20450531

  • Ikeda N, Shoji H, Murano Y, Mori M, Matsunaga N, Suganuma H, Ikeno M, Hisata K, Hirayama S, Ueno T, Miida T, Shimizu T. Effects of breastfeeding on the risk factors for metabolic syndrome in preterm infants. J Dev Orig Health Dis. 2014 Dec;5(6):459-64. doi: 10.1017/S2040174414000397. Epub 2014 Aug 28.

    PubMed 25167084

  • Saarinen UM, Kajosaari M. Breastfeeding as prophylaxis against atopic disease: prospective follow-up study until 17 years old. Lancet. 1995 Oct 21;346(8982):1065-9. doi: 10.1016/s0140-6736(95)91742-x.

    PubMed 7564787

  • Elison E, Vigsnaes LK, Rindom Krogsgaard L, Rasmussen J, Sorensen N, McConnell B, Hennet T, Sommer MO, Bytzer P. Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr. 2016 Oct;116(8):1356-1368. doi: 10.1017/S0007114516003354. Epub 2016 Oct 10.

    PubMed 27719686

  • Vazquez E, Barranco A, Ramirez M, Gruart A, Delgado-Garcia JM, Jimenez ML, Buck R, Rueda R. Dietary 2'-Fucosyllactose Enhances Operant Conditioning and Long-Term Potentiation via Gut-Brain Communication through the Vagus Nerve in Rodents. PLoS One. 2016 Nov 16;11(11):e0166070. doi: 10.1371/journal.pone.0166070. eCollection 2016.

    PubMed 27851789

  • Teixeira V, Voci SM, Mendes-Netto RS, da Silva DG. The relative validity of a food record using the smartphone application MyFitnessPal. Nutr Diet. 2018 Apr;75(2):219-225. doi: 10.1111/1747-0080.12401. Epub 2017 Dec 27.

    PubMed 29280547

  • Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

    PubMed 23851406

  • Nishida C, Ko GT, Kumanyika S. Body fat distribution and noncommunicable diseases in populations: overview of the 2008 WHO Expert Consultation on Waist Circumference and Waist-Hip Ratio. Eur J Clin Nutr. 2010 Jan;64(1):2-5. doi: 10.1038/ejcn.2009.139. Epub 2009 Nov 25.

    PubMed 19935820

  • Lohman TG, Harris M, Teixeira PJ, Weiss L. Assessing body composition and changes in body composition. Another look at dual-energy X-ray absorptiometry. Ann N Y Acad Sci. 2000 May;904:45-54. doi: 10.1111/j.1749-6632.2000.tb06420.x.

    PubMed 10865709

  • Klesges RC, Ward KD, Shelton ML, Applegate WB, Cantler ED, Palmieri GM, Harmon K, Davis J. Changes in bone mineral content in male athletes. Mechanisms of action and intervention effects. JAMA. 1996 Jul 17;276(3):226-30.

    PubMed 8667568

  • Peronnet F, Massicotte D. Table of nonprotein respiratory quotient: an update. Can J Sport Sci. 1991 Mar;16(1):23-9.

    PubMed 1645211

  • Gupta RD, Ramachandran R, Venkatesan P, Anoop S, Joseph M, Thomas N. Indirect Calorimetry: From Bench to Bedside. Indian J Endocrinol Metab. 2017 Jul-Aug;21(4):594-599. doi: 10.4103/ijem.IJEM_484_16.

    PubMed 28670546

  • Page P. Beyond statistical significance: clinical interpretation of rehabilitation research literature. Int J Sports Phys Ther. 2014 Oct;9(5):726-36.

    PubMed 25328834

  • Ko J, Yoo C, Xing D, Chun J, Gonzalez DE, Dickerson BL, Leonard M, Jenkins V, van der Merwe M, Slupsky CM, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Human Milk Oligosaccharide 2'-Fucosyllactose Ingestion on Weight Loss and Markers of Health. Nutrients. 2024 Oct 5;16(19):3387. doi: 10.3390/nu16193387.

    PubMed 39408354

Questions about this trial

What is this clinical trial studying?

A study testing 2'-Fucosyllactose and Maltodextrin in people with Weight Loss, run by Advanced Protein Technologies Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06547801, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.

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