Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Body Height
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Body Height
时间窗: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in height (meters) using a calibrated digital scale
Change in Body Weight
时间窗: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Change in body weight (kilograms) using a calibrated digital scale
Change in Hip Circumference
时间窗: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Hip circumference (centimeters) measured with a soft tape.
Change in Lean Body Mass
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline (0 weeks), midpoint (6 weeks), and endpoint (12 weeks)
Waist circumference (centimeters) measured with a soft tape.
Change in Body Mass Index (BMI)
时间窗: 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
时间窗: 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).
次要结局
- Change in Aerobic Capacity(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 White 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))