A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ability of Digest-All® to Improve Digestive Comfort and Function
LU IRB#:Â IRB-25-1
PI:Â Chad Kerksick, PhD
Description of Study
The purpose of this study is to evaluate the ability of a dietary supplement, Digest-ALL®, to improve digestive comfort and function.
Number of Visits
1 Virtual Visit
Time Commitment
Visit 1: 30 minutes
30-day supplementation with daily (5-minute) questionnaire
Weekly (5-10 minute) questionnaire
Compensation
$50 gift card and a certificate for 2 free bottles of Digest-ALL®
Points of Contact
Anthony Hagele and Joesi Morey
epnl@lindenwood.edu
Research Sample Needed
- 50 healthy men and women who routinely experience digestive discomfort.
Inclusion Criteria
- Participants who are between 18 – 60 years of age.
- Body mass index values will range from 20.0 to < 34.9 kg/m2. At least 80% of the cohort (40 participants) must have a body mass index less than 32.0 kg/m2. The ideal cohort average for body mass index will be less than 30 kg/m2 and must not exceed 31.0 kg/m2.
- Routinely (>1 time per week) experience digestive discomfort such as bloating, reflux, nausea, or fatigue after eating certain meals
- In good health absent of being overweight or obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders.
- Not currently diagnosed with or being treated for any cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders.
- Willing and able to: agree to the requirements and restrictions of this study, give voluntary consent, and carry out all study-related procedures.
Exclusion Criteria
- Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease, neurological condition/disease.
- Current treatment for kidney disease, renal failure, or has dialysis performed on regular intervals.
- Liver disease or some form of clinically diagnosed hepatic impairment.
- Diagnosed with Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL).
- Diagnosed with or is being treated for some form of thyroid disease.
- Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year.
- Diagnosed with some form of immune disorder (i.e., HIV/AIDS).
- History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Has had any form of surgical intervention to the digestive system.
- Newly prescribed a statin drug (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) within the past 3 months or you had your dosage changed by your physician within the past 3 months.
- Newly prescribed a blood pressure reduction medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) within the past 3 months or you had your dosage changed by your physician within the past 3 months.
- Current smoker (average of > 1 pack per day within the past 3 months) or has quit within the past six months. This includes all forms of nicotine.
- Intake of any dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc.
- Intake of any dietary supplements known or are purported to impact digestion or the body’s ability to digest food such as chitosan, fiber, digestive enzymes, phages, prebiotics, probiotics, etc.
- Intake of any medication (prescription or over-the-counter) or dietary supplement intended or known to provide gas relief
- Intake of any medication (prescription or over-the-counter) or dietary supplement intended or known to function as an antacid
- Intake of any medication (prescription or over-the-counter) or dietary supplement intended or known to function as a stool softener of laxative
- Participants who are lactating, pregnant or planning to become pregnant.
- History of alcohol or substance abuse in the 12 months prior to screening.
- Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol.
- They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study.
- Recent history (<3 months) of exercise training or weight loss (> 5%).
Are You Eligible?
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Information provided here reflects current IRB approval for this research. However, this information may be subject to change and updated accordingly.