The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
64
The study product is a dietary supplement manufactured by Standard Process Inc (i.e., Zypan®). One serving (i.e., two tablets) contains a proprietary blend (595 mg) of the following: Betaine hydrochloride, bovine pancreas Cytosol™ extract, pepsin (1:10,000), pancreatin (3x), stearic acid (vegetable source), ammonium chloride, bovine spleen, and ovine spleen. Non active ingredients will include cellulose and calcium stearate. Participants will be instructed to take two tablets three times daily with meals
The control supplement will not contain any of the active ingredients in Zypan® and will also be manufactured by Standard Process Inc. Two tablets will contain 435 mg of cellulose (42%), 288 mg rice bran powder (28%), 201 mg of calcium lactate powder (19.5%\*), 103 mg citric acid (10%), and 2.6 mg calcium stearate (0.25%)
Helfgott Research Institute
Portland, Oregon, United States
RECRUITINGProtein Assimilation
Concentrations of Amino Acids in Blood
Time frame: Baseline
Protein Assimilation
Concentrations of Amino Acids in Blood
Time frame: Week 4
Mineral concentrations in blood
Mineral concentrations in blood as measured by Genova Diagnostics NutrEval
Time frame: Baseline
Mineral concentrations in blood
Mineral concentrations in blood as measured by Genova Diagnostics NutrEval
Time frame: Week 4
Fat-soluble vitamin concentration in blood
Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Time frame: Baseline
Fat-soluble vitamins
Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Time frame: Week 4
Leeds Dyspepsia Questionnaire
Subjective measure of digestive symptoms
Time frame: Baseline
Leeds Dyspepsia Questionnaire
Subjective measure of digestive symptoms
Time frame: Week 4
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
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Subjective measure of Quality of life related to physical function
Time frame: Baseline
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
Subjective measure of Quality of life related to physical function
Time frame: Week 4