Effects of an Acid-Active Protease (P24) on Postprandial Aminoacidemia Following a Standardized Mixed-Protein Burger Meal in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postprandial total amino acid incremental area under the curve after the test meal with P24 versus placebo
研究概览
简要总结
The purpose of this study is to quantify the acute effects of an acid-active protease enzyme supplement (P24) on postprandial aminoacidemia following consumption of a standardized mixed-protein meal containing both plant- and animal-derived protein sources. Secondary objectives include evaluating the postprandial plasma peptidomic response, characterizing the postprandial hormonal responses (GLP-1, insulin, and GIP), and assessing the postprandial glucose response using standardized capillary blood glucose measurements. The study will also evaluate subjective responses including satiety and hunger and gastrointestinal symptoms.
详细描述
This study is a randomized, double-blind, placebo-controlled crossover trial designed to evaluate the acute effects of an acid-active protease enzyme supplement (P24) on postprandial amino acid availability after consumption of a standardized mixed-protein meal in healthy adults. Each participant will complete two morning test visits separated by an approximately 7-day washout period and will receive P24 during one visit and placebo during the other visit in randomized order. Each participant will therefore serve as his or her own control.
The primary objective is to compare postprandial circulating total amino acid responses between the P24 and placebo conditions following the test meal. Secondary objectives are to evaluate essential amino acids, branched-chain amino acids, postprandial glucose responses, postprandial hormonal responses including GLP-1, GIP, and insulin, plasma peptide profiles, and subjective responses such as hunger, satiety, and gastrointestinal symptoms.
Visits will be conducted in the morning after an overnight fast. Pre-visit standardization will include restrictions on vigorous exercise, alcohol, nicotine, and caffeine prior to each test visit, as well as instructions to maintain similar dietary intake before each study period. At the first visit, height and weight will be measured. At each visit, participants will complete brief questionnaires related to recent diet and activity, sleep, gastrointestinal symptoms, and subjective appetite.
An indwelling intravenous catheter will be placed in a forearm vein for repeated venous blood collection. Venous blood samples will be collected at baseline and at multiple postprandial timepoints over 180 minutes following meal consumption. Capillary blood glucose will also be assessed at matched timepoints using standardized finger-prick measurements. Participants will remain on site during the postprandial observation period and will be monitored for adverse events and procedure-related symptoms.
The test meal will be a standardized mixed-protein burger meal designed to include both animal-derived and plant-derived protein sources. Meal composition, preparation, and serving procedures will be standardized across visits. Participants will consume the meal with water within a defined time window. On each study day, participants will receive either one P24 capsule or one matching placebo capsule immediately prior to the meal according to the study randomization schedule. Active and placebo products will be identical in appearance to maintain blinding.
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, Investigator)
盲法说明
This is a double-blind study. Participants and study staff conducting outcome assessments will be blinded to treatment assignment. P24 and placebo capsules are identical in appearance and are labeled according to a computer-generated randomization schedule prepared by a team member not involved in data collection
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 45-75 years
- •BMI 18.5-35 kg/m2
- •Able to provide informed consent and comply with study procedure
- •Willing to consume the standardized mixed-protein test meal
排除标准
- •BMI outside of 18.5-35 kg/m2
- •Gastrointestinal disorders or malabsorption syndromes that could affect digestion/absorption (e.g., inflammatory bowel disease, celiac disease)
- •Diagnosed diabetes
- •Current use of medications or supplements that materially affect glucose metabolism or digestion (e.g., GLP-1 receptor agonists, chronic digestive enzyme supplementation)
- •Resting blood pressure ≥ 140/90 mmHg
- •Self-reported cancer within past 5 years
- •Known allergy or intolerance to meal components or capsule ingredients
- •Self-reported anemia or other conditions that increase risk from blood draws
- •Pregnancy or breastfeeding
- •Current smoking or nicotine use, heavy alcohol use (defined as > 5 drinks/day or > 15 drinks/week), or other factors that in the investigator's judgment make participation unsafe
研究组 & 干预措施
Placebo
Matching placebo capsule containing microcrystalline cellulose, administered prior to the standardized mixed-protein burger meal. Placebo capsules are identical in appearance to the active product and are used to maintain blinding in the randomized crossover design.
干预措施: Placebo (Other)
Protease enzyme supplement
P24 is an acid-active protease enzyme supplement administered as one capsule prior to the standardized mixed-protein burger meal. The active product contains P24 and is compared with a matching placebo capsule in a randomized, double-blind crossover design in healthy adults
干预措施: Protease enzyme supplement (Dietary Supplement)
结局指标
主要结局
Postprandial total amino acid incremental area under the curve after the test meal with P24 versus placebo
时间窗: 0 to 180 minutes after meal consumption
Incremental area under the curve for circulating total amino acids following consumption of the standardized test meal with P24 compared with placebo.
次要结局
- Postprandial essential amino acid and branched-chain amino acid responses after the test meal with P24 versus placebo(0 to180 minutes after meal consumption)
- Postprandial plasma hormone responses after the test meal with P24 versus placebo(Baseline, 60 minutes after meal consumption, and 180 minutes after meal consumption)
- Postprandial plasma peptide profile after the test meal with P24 versus placebo(Baseline, 60 minutes after meal consumption, and 180 minutes after meal consumption)
- Postprandial capillary blood glucose responses after the test meal with P24 versus placebo(Baseline and 30, 60, 90, 120, and 180 minutes after meal consumption)