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Ability of Digest-All® to Improve Digestive Comfort and Function

Ability of Digest-All® to Improve Digestive Comfort and Function

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ability of Digest-All® to Improve Digestive Comfort and Function

LU IRB#: IRB-25-1
PI: 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.