This study aims to show how digestive enzyme supplements help the body break down fats, proteins, and carbohydrates, especially after eating a high-macronutrient meal. Digestive enzymes are essential for nutrient absorption, but some people-such as those with certain medical conditions or high-protein diets-may not produce enough on their own. Poor digestion can lead to bloating, discomfort, and gut imbalances. This clinical trial tests a delayed-release, porcine-derived enzyme blend to see if it improves digestion and reduces symptoms like bloating and gas after eating a high-macronutrient meal.
This study explores the potential benefits of digestive enzyme supplementation for individuals consuming high-macronutrient meals. Digestive enzymes play an important role in breaking down macronutrients to facilitate nutrient absorption. While the body naturally produces these enzymes, certain factors such as genetic predisposition, aging, or high dietary intake of fats and proteins can strain the digestive system, leading to incomplete digestion and gastrointestinal discomfort. High-macronutrient meals require significant enzymatic activity for proper breakdown, and inadequate digestion can result in symptoms like bloating, indigestion, and changes in gut microbiota. Undigested fats and proteins in the colon can contribute to digestive discomfort, while improperly broken-down carbohydrates may lead to increased gas production and microbial imbalances. These effects can impact overall digestive efficiency, nutrient availability, and gut health. This clinical trial investigates the efficacy of a delayed-release, porcine-derived enzyme blend containing 20,000 lipase units in improving digestion and gastrointestinal well-being. The study follows a randomized, placebo-controlled, crossover design to assess how this enzyme supplement affects macronutrient breakdown and post-meal symptoms. Researchers will evaluate both immediate effects after a single dose and longer-term benefits after seven days of supplementation, including its impact on quality of life. The findings may provide insight into whether digestive enzyme supplementation can enhance nutrient absorption and alleviate digestive discomfort in individuals consuming high-macronutrient diets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
24
Oral
Oral
Apex Trials
Guelph, Ontario - on, Canada
To Assess the effect of the TP on lipid digestion after a single dose using area under the curve (AUC0-t) - Total Triglycerides
Comparison of total Triglycerides (TG) up to 360 min in response to the high-macronutrient meal.
Time frame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
To assess the effect of the TP on lipid digestion after a single dose using maximum concentration (Cmax): Total Triglycerides
Comparison of total triglycerides up to 360 min in response to the high-macronutrient meal.
Time frame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
To assess the effect of the TP on lipid digestion after a single dose using time to reach maximum concentration (Tmax) - Total Triglycerides
Comparison of total triglycerides up to 360 min in response to the High-macronutrient meal.
Time frame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
To assess the effect of the TP on protein digestion after a single dose using area under the curve (AUC0-t):Total Free Amino Acids (TFAA)
Comparison of total leucine up to 360 min in response to the High-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on protein digestion after a single dose using maximum concentration (Cmax):Total Free Amino Acids(TFAA)
Comparison of total free amino acids up to 360 min in response to the High-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on protein digestion after a single dose using time to reach maximum concentration (Tmax):Total Free Amino Acids(TFAA)
Comparison of total free amino acids up to 360 min in response to the High-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Glucose
Comparison of glucose up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Glucose
Comparison of glucose up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Glucose
Comparison of glucose up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Insulin
Comparison of insulin up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Insulin
Comparison of insulin up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Insulin
Comparison of insulin up to 360 min in response to the high-macronutrient meal.
Time frame: 30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes
To assess the effect of TP on appetite after a single dose using VAS score - Pre dose and Pre Meal
Change from pre-dose 30,90,120,180,240 and 360 min after the start of high-macronutrient meal.
Time frame: 30,90,120,180,240,300 and 360 minutes
To assess the effect of TP on gastrointestinal (GI) symptoms after a single dose using VAS score - Pre -Dose and Pre Meal
Change from pre-dose 30,90,120,180, and 360 min after the start of high-macronutrient meal.
Time frame: 30,90,120,180, and 360 minutes
To assess the effect of TP on abdominal distention after a single dose in waist Circumference - Pre -Dose and Pre Meal
Change from pre-dose 30,90,120,180, and 360 min after the start of high-macronutrient meal.
Time frame: 30,90,120,180, and 360 minutes
To assess the effect of the TP on GI-related quality of life after 7 days of supplementation assessed by the PROMIS Scale V1.1 GI Gas and Bloating
Change from baseline to 7 days in severity rating of GI symptoms.
Time frame: 7 days
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