The study is a self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.
The study is a prospective self-controlled study in which we will assess the nutritional effects of Kate Farm Peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment diet regimen. The duration of the study will be 12 weeks. We plan to recruit a total of 30 patients. Patients will undergo a baseline measurement of their height, weight, symptom burden, resting energy expenditure, inflammation, and microbiome. After study initiation, patient will undergo repeat testing at 1- and 3-months post-enrollment. Including the screening and baseline visits, there will be a total of 4 visits required to complete the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5
Kate Farm Peptide 1.5 nutritional Formula
Stanford University School of Medicine
Redwood City, California, United States
Change from baseline in Gastroparesis Cardinal Symptom Index (GCSI) Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula.
9-item measure of severity of gastroparesis symptoms on a scale of 0-5 (none to worst) Higher values represent a worse outcome.
Time frame: Screening, Baseline and through end of study (12 weeks)
Change in Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Disorders-Symptom Severity Index (PAGI-SYM) score as measure of the effect of KF Peptide 1.5 nutritional formula.
20-item measure of upper gastrointestinal symptom severity on a scale of 0-5 (none to worst) Higher values represent a worse outcome.
Time frame: Baseline through end of study (12 weeks)
Total energy requirement
Measurement of resting energy expenditure by indirect calorimetry
Time frame: At Baseline and end of study (12 weeks)
Inflammatory markers
CRP C-reactive protein
Time frame: Baseline through end of study (12 weeks)
Weight
weight (kg)
Time frame: Baseline through end of study (12 weeks)
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