Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

Short Physical Performance Battery (SPPB)

SPPB is an objective measurement instrument of balance, lower lowerextremity strength, and functional capacity in older adults (\>65 years of age). Three domains, which include balance, usual or self-selected gait speed, and lower limb strength, are assessed by a three-stage balance test (feet side-by-side, semitandem, and tandem positions), a 3-m or 4-m gait speed test (time spent to walk the course), and a repetitive chair stand test (five times chair sit-to-stand test), respectively. A 0- to 12-point scale is used to score the sum of the three assessments, with point values corresponding with greater levels of function and lower disability, whereas lower point values correspondwith lower levels of physical function and higher disability, respectively

Time frame: Change from Baseline SPPB at 3 months and at 6 months

Timed 25 Foot Walk (T25FW)

The T25-FW is a quantitative test of leg mobility and function based on a timed 25-foot walk. The patient is directed to one end of a path and instructed to walk as quickly but safely as possible. The task is immediately repeated by asking the patient to return by walking the same distance. Patients may use assistive devices while performing this task.

Time frame: Change from Baseline T25FW at 3 months and at 6 months

Timed Up&Go Test (TUG)

TUG measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 5is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from frominitial getting up to re-seating. Patients are compared with the mean time of adults in their age group: 60 to 69, 70 to 79, and 80 to 99 years of age.

Time frame: Change from Baseline TUG at 3 months and at 6 months

Trail Making Test (TMT)

The TMT measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles are distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, Deficient \> 78 seconds, Rule of most in 90 seconds Trail B: Average 75 seconds, Deficient \> seconds, Rule of Thumb Most in 3 minutes

Time frame: Change from Baseline TMT at 3 months and at 6 months

Symbol Digit Modalities Test (SDMT)

The SDMT is a neuropsychological test used to assess cognitive processing speed, attention, and visual-motor coordination. The test involves matching symbols to corresponding numbers based on a key, and participants must quickly and accurately pair the symbols with the correct numbers within a set time limit. The test evaluates attention, working memory, and mental flexibility. A higher score indicates better cognitive processing speed and accuracy.

Time frame: Change from Baseline SDMT at 3 months and at 6 months

Stroop Colour Word Test (SCWT)

ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task and to name colors in the second and third tasks. It is necessary to mark not only any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92.

Time frame: Change from Baseline SCWT at 3 months and at 6 months

Hospital Anxiety and Depression Scale (HADS)

The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale, the score is the sum of the respective seven items (ranging from 0 to 21). The two sub-scales, anxiety and depression, have been found to be beindependent measures. In its current form, the HADS is now divided into four stages: Scores of 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)

Time frame: Change from Baseline HADS at 3 months and at 6 months

Modified Fatigue Impact Scale (MFIS)

The MFIS is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items, while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can cangenerally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.

Time frame: Change from Baseline MFIS at 3 months and at 6 months

EuroQoL- 5D (EQ-5D)

EQ-5D is an instrument that evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to the ED-5D permit finding 243 unique health states or can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health.

Time frame: Change from Baseline EQ-5D at 3 months and at 6 months

Irritable Bowel Syndrome-Quality of Life (IBS-QOL)

The IBS-QOL is a self-assessment tool for quality of life. The IBS-QOL consists of 34 items, each with a five-point response scale: from 1 (not at all) to 5 (very much). Individual responses to the 34 questions are summed and averaged to obtain a total score, which is then transformed into a scale of 0 to 100 for ease of interpretation, where higher scores indicate better quality of life.

Time frame: Change from Baseline IBS-QOL at 3 months and at 6 months

Silver Index (SI)

The SI is an objective test to identify the risk of falling, which is carried out using the Hunova robotic platform. It consists of seven domains: (i) static balance (ii) dynamic balance (iii) reactive balance (iv) sensory sensoryintegration (v) stability limits (vi) sitting-to-standing position (vii) gait speed. At the end of the evaluation, you get a percentage that indicates risk of falling

Time frame: Change from Baseline SI at 3 months and at 6 months

Bioimpedance analysis (BIA)

BIA measures the opposition of body tissues to alternating current, that is, the impedance of the whole body. The two raw parameters derived from this analysis are resistance (Rz) and reactance (Xc). Rz is inversely related to water content in biological tissues, while Xc depends on the capacitance properties of the cell membrane, providing information on cellular health, integrity, and density From Rz and Xc, the phase angle (PhA), which is related to cellular health and muscle quality, can be calculated directly. Lower PhA values have typically been observed in subjects with severe pathological conditions and have been correlated with worse outcomes; in contrast, higher PhA values are indicative of better overall health, strength, and muscle function.

Time frame: Change from Baseline BIA at 3 months and at 6 months