Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake

NCT02938247 | Completed

• 1 other identifier: F3kc-002-CNI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people

Conditions

Malnutrition

Keywords

Malnutrition; Geriatric subjects; Nursing home

Outcome Measures

Primary Outcomes (3)

• Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)

  The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain

  At screening examination (study days -3 to -1)

• Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)

  The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain

  At end of study (study day 8)

• Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)

  The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain

  At study days 1-8

Secondary Outcomes (8)

• Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)

  At study days 1 and 7

• Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)

  At study days 1-7

• Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)

  At study days 1-7

• Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS

  At study days 1-7

• Use of ONS assessed by consumption

  At study days 1-7

Other Outcomes (1)

• Adverse Events

  At study days 1-8

Study Arms (1)

Single-arm study

EXPERIMENTAL

High caloric, high protein ONS, three portions daily, total dose of 400 kcal/day for 7 consecutive days, oral administration

Dietary Supplement: High caloric, high protein ONS

Interventions

High caloric, high protein ONS DIETARY_SUPPLEMENT

Single-arm study

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Sex: male/female
• Age: 65 years or older
• Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
• Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
• Written informed consent

You may not qualify if:

• Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
• Subjects with galactosaemia or similar metabolic disorders
• Subjects with severely impaired gastrointestinal function or complete failure
• Subjects with insulin-requiring diabetes
• Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
• Subjects reporting frequent occurrence of migraine attacks
• Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
• Existing mouth abnormalities, which cause impaired gustatory sense
• Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
• Subjects passing through chemotherapy (last cycle \< 2 months ago)
• Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
• Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
• Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
• Subjects with need of a special diet contradicting the intake of the ONS
• History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Cornelius Koch, MD

  SocraTec R&D GmbH, Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: October 19, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)