Weight Loss
Conditions
Keywords
2'-Fucosyllactose, Inflammation, Functional capacity
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.
Interventions
DIETARY_SUPPLEMENT2'-Fucosyllactose
3 g/day of powder orally once daily
DIETARY_SUPPLEMENTMaltodextrin
3 g/day of powder orally once daily
Sponsors
Advanced Protein Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hip Circumference | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Hip circumference (centimeters) measured with a soft tape. |
| Change in Lean Body Mass | 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). |
| Change in Body Fat | 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). |
| Change in Bone Mineral Content | 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). |
| Change in Waist Circumference | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Waist circumference (centimeters) measured with a soft tape. |
| Change in Body Weight | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Change in body weight (kilograms) using a calibrated digital scale |
| Change in Body Height | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Change in height (meters) using a calibrated digital scale |
| Change in Body Mass Index (BMI) | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Body Mass Index (BMI) calculated using weight and height, expressed in kg/m². |
| Change in Fat Mass | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in White Blood cell | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | White Blood cells (K/uL) were analyzed from collected fasting whole blood samples. |
| Change in Red Blood cell | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Red Blood cells (M/uL) were analyzed from collected fasting whole blood samples. |
| Change in Hemoglobin | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Hemoglobins (g/dL) were analyzed from collected fasting whole blood samples. |
| Change in Aerobic Capacity | baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks) | Change in peak oxygen uptake (L/min) from baseline. |
Countries
United States
Outcome results
None listed