Clinical trial NCT06547801: Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
Official title: Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: 2'-Fucosyllactose
Inflammation
Functional capacity
Lead sponsor: Advanced Protein Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Body Height
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Body Mass Index (BMI)
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Fat Mass
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Lean Body Mass
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Body Fat
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Bone Mineral Content
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Waist Circumference
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Hip Circumference
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Secondary outcomes:
measure: Change in Aerobic Capacity
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in White Blood cell
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Red Blood cell
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
measure: Change in Hemoglobin
timeFrame: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station
state: Texas
Study officials:
affiliation: rbkreider@tamu.edu
name: Richard B Kreider, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Peronnet F, Massicotte D. Table of nonprotein respiratory quotient: an update. Can J Sport Sci. 1991 Mar;16(1):23-9.
citation: 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.
citation: Page P. Beyond statistical significance: clinical interpretation of rehabilitation research literature. Int J Sports Phys Ther. 2014 Oct;9(5):726-36.