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| ID | Type | Description | Link |
|---|---|---|---|
| APT00001 | Other Grant/Funding Number | Advanced Protein Technologies Corp. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2'-fucosyllactose | Experimental | 3 g/day of 2'-FL powder orally once daily for 12 weeks |
|
| Maltodextrin | Placebo Comparator | 3 g/day of banana-flavored maltodextrin powder orally once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2'-Fucosyllactose | Dietary Supplement | 3 g/day of powder orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aerobic Capacity | Change in peak oxygen uptake (L/min) from baseline. | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) |
| Change in White Blood cell | White Blood cells (K/uL) were analyzed from collected fasting whole blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Kreider, Professor | rbkreider@tamu.edu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise & Sport Nutrition Lab, Department of Kinesiology and Sport Management, Texas A&M University, College Station | College Station | Texas | 77843 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37372011 | Background | 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. | |
| 20450531 |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C031420 | 2'-fucosyllactose |
| C008315 | maltodextrin |
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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.
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| Maltodextrin |
| Dietary Supplement |
3 g/day of powder orally once daily |
|
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) |
| baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) |
| Change in Red Blood cell | 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 | Hemoglobins (g/dL) were analyzed from collected fasting whole blood samples. | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) |
| 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. |
| 25167084 | 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. |
| 7564787 | 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. |
| 27719686 | Result | 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. |
| 27851789 | 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. |
| 29280547 | 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. |
| 23851406 | 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. |
| 19935820 | 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. |
| 10865709 | 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. |
| 8667568 | 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. |
| 1645211 | Result | Peronnet F, Massicotte D. Table of nonprotein respiratory quotient: an update. Can J Sport Sci. 1991 Mar;16(1):23-9. |
| 28670546 | 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. |
| 25328834 | Result | Page P. Beyond statistical significance: clinical interpretation of rehabilitation research literature. Int J Sports Phys Ther. 2014 Oct;9(5):726-36. |
| 39408354 | Derived | 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. |
| D010335 | Pathologic Processes |