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

NCT06547801 | Completed

• 2 other identifiers: IRB2022-1559FAPT00001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss

Keywords

2'-Fucosyllactose; Inflammation; Functional capacity

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Change in Aerobic Capacity

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

• Change in White Blood cell

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

• Change in Red Blood cell

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

• Change in Hemoglobin

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

Study Arms (2)

2'-fucosyllactose

EXPERIMENTAL

3 g/day of 2'-FL powder orally once daily for 12 weeks

Dietary Supplement: 2'-Fucosyllactose

Maltodextrin

PLACEBO COMPARATOR

3 g/day of banana-flavored maltodextrin powder orally once daily for 12 weeks

Dietary Supplement: Maltodextrin

Interventions

2'-Fucosyllactose DIETARY_SUPPLEMENT

3 g/day of powder orally once daily

2'-fucosyllactose

Maltodextrin DIETARY_SUPPLEMENT

3 g/day of powder orally once daily

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Protein Technologies Corporation: lead

Study Sites (1)

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

College Station, Texas, 77843, United States

Location

Related Publications (15)

• 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.

  PMID: 37372011 BACKGROUND

• 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.

  PMID: 20450531 BACKGROUND

• 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.

  PMID: 25167084 BACKGROUND

• 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.

  PMID: 7564787 BACKGROUND

• 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.

  PMID: 27719686 RESULT

• 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.

  PMID: 27851789 RESULT

• 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.

  PMID: 29280547 RESULT

• 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.

  PMID: 23851406 RESULT

• 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.

  PMID: 19935820 RESULT

• 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.

  PMID: 10865709 RESULT

• 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.

  PMID: 8667568 RESULT

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

  PMID: 1645211 RESULT

• 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.

  PMID: 28670546 RESULT

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

  PMID: 25328834 RESULT

• 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.

  PMID: 39408354 DERIVED

MeSH Terms

Conditions

Weight Loss; Inflammation

Interventions

2'-fucosyllactose; maltodextrin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Richard B Kreider, Professor

  rbkreider@tamu.edu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: August 9, 2024
• Study Start: May 4, 2023
• Primary Completion: August 20, 2023
• Study Completion: February 22, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)