NCT07534020已完成不适用
A Randomized, Single-Blind, Crossover Pilot Trial to Assess the Effects of Proprietary Beverages on Amino Acids and Acute Appetite Hormone Response in Healthy Adults
Shaklee Corporation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax) above baseline for essential amino acids
研究概览
简要总结
The primary objective of this study is to evaluate post-meal amino acid in response to a proprietary beverages in generally healthy adults.
详细描述
The primary objective of this study is to evaluate post-meal amino acid, appetite hormones, and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults compared to control. It is hypothesized that beverages will result in an increase in essential amnio acids, as well as appetite hormones and feelings of satiety, compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, ≥20 to ≤50 years of age.
- •Body mass index (BMI( ≥18.5 and <25.0 kg/m
- •Self-reported regular consumer (≥5 days/week) of breakfast.
- •Women who are either pre- or post-menopausal. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior.
- •Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
- •Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
排除标准
- •Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.
- •Weight loss or gain >4.5 kg within 90 days.
- •History of gastrointestinal surgery for weight reducing purposes.
- •History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) or extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
- •History of unconventional sleep patterns (e.g., night shift) or a diagnosed sleep disorder or chronic medical condition that may impact appetite (in the judgment of the Investigator).
- •Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months.
- •Use of hemp/marijuana products within 60 days. Occasional use (e.g., once or twice a month) within 60 days is allowed.
- •Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days.
- •Unstable use (initiation or change in dose) within 30 days of hormonal contraceptives.
- •Use of any dietary supplements, except for a conventional once daily multivitamin/mineral supplement.
- •Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
- •Exposed to any non-registered drug product within 30 days prior.
- •A score of <7 on the Vein Access Scale Assessment.
- •History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- •Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
- •Known allergy to any ingredients contained in the study product or study foods.
- •Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days.
- •History or presence of cancer in the prior 2 years, except for nonmelanoma skin cancer.
- •History of any major trauma or major surgical event within 2 months.
- •Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose within 30 days) of sex hormones for contraception.
- •An employee or representative who has a financial interest in Shaklee Corporation.
- •Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
研究组 & 干预措施
Control non-carbonated protein beverage followed by Test carbonated protein beverage
Experimental
干预措施: Test carbonated protein beverage (Other)
Test protein beverage followed by Control protein beverage
Experimental
干预措施: Control protein beverage. (Other)
Test carbonated protein beverage followed by Control non-carbonated protein beverage
Experimental
干预措施: Control non-carbonated beverage (Other)
Test protein beverage followed by Control protein beverage
Experimental
干预措施: Test protein beverage (Other)
Test carbonated protein beverage followed by Control non-carbonated protein beverage
Experimental
干预措施: Test carbonated protein beverage (Other)
Control protein beverage followed by Test protein beverage
Experimental
干预措施: Test protein beverage (Other)
Control protein beverage followed by Test protein beverage
Experimental
干预措施: Control protein beverage. (Other)
Control non-carbonated protein beverage followed by Test carbonated protein beverage
Experimental
干预措施: Control non-carbonated beverage (Other)
结局指标
主要结局
Maximum concentration (Cmax) above baseline for essential amino acids
时间窗: Up to 2 hours post-beverage consumption
次要结局
- Positive area under the curve (AUC) for essential amino acids(Up to 2 hours post-beverage consumption)
- Time to Cmax (Tmax) for essential amino acids(Up to 2 hours post-beverage consumption)
- Maximum concentration (Cmax) above baseline for appetite hormones(Up to 2 hours post-beverage consumption)
- Positive area under the curve (AUC) for appetite hormones(Up to 2 hours post-beverage consumption)
- Time to Cmax (Tmax) for appetite hormones(Up to 2 hours post-beverage consumption)
- Individual and composite appetite visual analog scale (VAS) ratings(Up to 2 hours post-beverage consumption)
研究者
研究点 (1)
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