Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      This trial will investigate the potential of a bioactive peptide to reduce symptoms of
      digestive discomfort in a generally healthy elderly population. Participants will consume the
      bioactive peptide for 12 weeks and various measures indicating an improvement in health and
      well being will be taken throughout the trial. It is believed that consumption of the study
      product will reduce the severity of digestive discomfort, reduce chronic inflammation,
      improve blood glucose metabolism and improve physical performance.
    

Detailed description: 
      Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort
      will be randomised. Subjects will be randomised to receive either the Bioactive peptide or
      placebo for a total of 12 weeks.

      Subjects will undergo an initial phone screen and will be asked questions regarding their age
      and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a
      screening visit. The study will involve 5 visits over a 13 to 16 week period.

      At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and
      the overall details of the study will be explained and informed consent obtained. Vitals and
      Medical history, demographic data and concomitant medication will be recorded.

      Subjects will be asked questions relating to their digestive symptoms, including symptoms of
      abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive
      Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire
      (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score
      will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A
      fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and
      blood lipids will be measured.

      Subjects will be provided with a stool collection kit and instructions for collecting and
      storing. Subjects will collect a stool sample at home, within 24 hours of their next visit
      and bring it to the clinic at their next visit.

      If the subject meets the eligibility criteria, they will be invited to participate in the
      study and will be given an appointment to return to the study site within 4 weeks for their
      baseline/week 0 visit.

      Subjects will attend visit 2 fasting. The inclusion and exclusion criteria will be reviewed
      and eligibility for study entry confirmed. An Oral Glucose Tolerance Test will be performed.
      Haematology, biochemistry and blood lipids will also be measured.

      A urine sample will be collected and also stored frozen for analysis of metabolites.

      Vitals, anthropometric measurements, concomitant medication and any adverse events will be
      recorded and The Short Physical Performance Battery (SPPB) test will be performed.

      Subjects will complete the Digestive Symptom Frequency Questionnaire and the hand-grip and
      chair-stand tests will be performed. A DEXA scan will be performed and muscle and fat mass
      recorded.

      Subjects will be randomized to receive the Bioactive peptide or placebo and receive a 4 week
      supply of product and instructions for dosing. Subjects will be provided with a stool
      collection kit and instructions for collecting and storing. Subjects will collect a stool
      sample at home, within 24 hours of their next visit and bring it to the clinic at their next
      visit.

      Subjects will return for visits at week 4, week 8 and week 12.

      A similar regimen will be followed for visits at week 4, week 8 and week 12.

      The site, investigator, protocol, informed consent form and any other pertinent documents for
      this study will be approved by: Cork Research Ethics Committee of the Cork Teaching
      Hospitals, Lancaster Hall, 6 Little Hanover Street, Cork.

      The investigator is responsible for ensuring that all source documents (i.e. study and/or
      medical records) are completed and maintained according to the study protocol, Good Clinical
      Practice (GCP) and are available at the site.

      LIST OF ABBREVIATIONS AND DEFINITION OF TERMS

      ANCOVA Analysis of co-variance AUC Area Under the Plasma Concentration BMI Body mass index BP
      Blood pressure CI Confidence interval CRF Case Report Form CRO Contract Research Organization
      EFSA European Food Safety Authority GCP Good Clinical Practice GMP Good Manufacturing
      Practice HbAIc Glycated haemoglobin (A1c) ICH International Conference on Harmonization INCI
      The International Nomenclature of Cosmetic Ingredients ITT Intent-to-treat kDa Kilodalton kg
      Kilogram L Liter MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin
      concentration MCV Mean corpuscular volume MCPs Marine collagen peptides MedDRA Medical
      Dictionary for Regulatory Activities mITT Modified intention-to-treat mL Milliliter mmHg
      Millimeter of mercury mmol/mol Millimoles per mole OGTT Oral glucose tolerance test PPP Per
      protocol population RDW Red cell distribution width SAE Serious adverse event SAP Statistical
      analysis plan VLDL Very low-density lipoprotein WHO World Health Organisation
    

Intervention name(s): Bioactive hydrolysate
Intervention type(s): Dietary Supplement
Intervention description(s): Participants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention