Investigating the effects of cow, goat or sheep milk on nutrition and digestive comfort in older wome

Not Applicable

Recruiting

• Conditions: Age-related gastrointestinal discomfort; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622001161718
• Lead Sponsor: Riddet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-24
• Last Update Posted: 21 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Women who live independently and are free from serious medical illness such as cancer, uncontrolled diabetes or cardiovascular disease, with a Body Mass Index between 18.5 to 30 kg/m2, and do not undertake more than 2 hours of structured exercise each day.

Exclusion Criteria

•Inability to give informed consent
•Taken antibiotics within the month before starting the study
•Use of certain prescribed medication or recreational drugs within the last three months that could affect the gastrointestinal tract: opioids, non-steroidal anti-inflammatory drugs, proton pump inhibitors, laxatives, prebiotic or probiotic supplements.
•Medical history of gastrointestinal surgery or disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease), cardiorespiratory problems, uncontrolled diabetes mellitus, bleeding disorders, sleep disorders, psychiatric conditions (major depressive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder)
•Alarm features associated with significant gastrointestinal or other disorders, such as burning pain in the epigastrium which increases during the night and wakes up the patient; frequent vomiting; loss of appetite; lower gastrointestinal bleeding; odynophagia; dysphagia; palpable abdominal mass; lymphadenopathy; jaundice.
•Significant dietary changes within the month before starting the trial (i.e., being on a controlled diet or dietary weight loss regimen)
•Dairy intolerance of, or ruminant milk allergy
•High habitual milk intake (> 500 mL per day on average)
•Malnutrition Screening Tool (MST) score of 2 or more points
•Cigarette smoking or other use of tobacco or nicotine-containing products
•Excessive alcohol intake >20g of pure alcohol (2 drinks)/d on average (>21 standard drinks a week)
•Inability or unwillingness to comply with the study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in abdominal pain scores from the Gastrointestinal Symptom Rating Scale (GSRS).<br><br>The GSRS is a validated instrument with a 1-week recall that assesses symptom severity using a 7-grade Likert scale, ranging from 1 (no discomfort at all”) to 7 (very severe discomfort”).<br>[Measured weekly for the duration of the study (from 2 weeks prior to intervention commencement to 12 weeks post-intervention commencement).];Changes in bowel comfort scores from the Gastrointestinal Symptom Rating Scale (GSRS).[Measured weekly for the duration of the study (from 2 weeks prior to intervention commencement to 12 weeks post-intervention commencement).];Changes in protein intake, using 3-day diet records.[Baseline (end of 2nd week of lead-in phase) and at the end of the intervention (12 weeks post-intervention commencement).]