The aim of this study is to determine the effects of prebiotic fibre delivered in ONS on the microbiome in older adults with or at risk of malnutrition and/or using ONS.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ziekte gerelateerde ondervoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the change in gut microbiota
bifidobacteria levels (ΔV3-V1).
Secondary outcome
Secondary outcome parameters in this study are:
- Changes in gut microbiota composition (ΔV3-V1 analysed between and within
groups).
- Fecal pH and Total short-chain fatty acids (SCFA) (ΔV3-V1 analysed between
and within groups).
- Stool frequency and consistency assessed by the Bristol Stool Form Scale
(BSFS) (ΔV3-V1 analysed between and within groups)
Background summary
The World Health Organization (WHO) reports the global prevalence of
malnutrition showing that around 390 million adults are underweight. According
to the Medical Nutrition International Industry dossier, the estimated number
of people suffering from malnutrition in Europe is 33 million. The prevalence
of malnutrition can be associated with specific groups of disease and settings
of care. A large-scale survey performed in Ireland, UK, and The Netherlands
highlights increased risk of malnutrition in hospitalized patients suffering
from cancer, hematological, respiratory, and gastrointestinal disease. In the
elderly population the prevalence of malnutrition is higher in the
rehabilitation and long-term care (29.0%), hospitals (22.0%), and nursing homes
(18.0%) compared to the home-care (9.0%) and outpatient services (6.0%) and the
community (3.0%).
Disease related malnutrition (DRM) is the consequences of certain diseases in
addition to inadequate dietary intake and nutritional support that negatively
impact the recovery. In addition to DRM, several other factors such as the
patient*s overall health status, age, prescribed medications (including
antibiotics and chemotherapy), and poor dietary habits significantly influence
recovery and clinical outcomes. The ageing process is linked with numerous
changes in GI physiology and functionality. These changes can influence the
quantity and variety of nutrients reaching the small intestine and colon,
consequently altering the composition and functionality of the intestinal
microbiota in these areas. Prebiotics are defined as 'a substrate that is
selectively utilized by the host microorganisms conferring a health benefit'
(e.g. soluble fibres).
Study objective
The aim of this study is to determine the effects of prebiotic fibre delivered
in ONS on the microbiome in older adults with or at risk of malnutrition and/or
using ONS.
Study design
This is a randomised controlled, double blind, parallel-group, multi-country
study.
A randomised controlled design is chosen for reason of scientific credibility.
The study is designed as a double-blind study. As it might be hard to enrol the
study target population in studies collecting stool samples a multi-country set
up has been chosen; the Netherlands and Belgium.
Intervention
Subjects that are eligible for study participation will be randomly allocated
to receive either the Test Product or the Control Product for a period of 4
weeks.
Study burden and risks
The burden on the subjects is kept minimal. Subjects are mainly asked to
complete questionnaires and diaries during screening and/or the intervention
period. The expected risks associated with the test and control products are
minimal.
During the intervention period, the number of visits to the research center is
limited (3x). In consultation, the visits can also take place at the
participants' homes in order to relieve the participants.
A large patient population can benefit from the results of the research.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. 65 years of age or older
2. Identified as at medium or high risk of malnutrition based on:
a) MNA-SF score between 0 - 11 and / or
b) are prescribed with ONS
3. In need of 2 servings of oral nutritional support/day (300 kcal; 12 gr
protein per serving).
4. Willing to maintain dietary habits for the duration of the study.
5. Written informed consent from subject.
6. Have access to a freezer and willing to store the stool samples in it.
Exclusion criteria
1. Requirement for a fibre-free diet.
2. Have used nutritional supplements with fibre/prebiotics and/or probiotics
content at any point during 3 weeks prior to start study (V1) and / or will not
refrain from using these kinds of products during the study period.
3. Admitted to hospital.
4. Excessive alcohol consumption (use of > 10 units per week or > 2 units per
day on average during the past 6 months).
5. Active smoker (1 cigarette or more per week) or quit smoking less than 5
years ago.
6. Known allergy to cow*s milk protein.
7. Known allergy to soy protein
8. Known galactosaemia.
9. Known hepatic encephalopathy.
10. Any antecedents of digestive surgery (except for appendectomy and
cholecystectomy performed more than 2 years before the screening visit), or
plan for such surgery during the study.
11. Known Irritable Bowel Syndrome.
12. Known lactose intolerance without using lactase.
13. Known history of intestinal polyp removal within 3 months prior to the
study.
14. Known history of Immunotherapy.
15. Known history of GI cancer.
16. Active cancer treatment or within 12 months prior the study
17. Diagnose of Celiac Disease.
18. Received antibiotics (systemic) within 4 weeks prior to study.
19. Patients following a vegan or vegetarian diet.
20. Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn*s
disease) or SCCAI >5 (ulcerative colitis).
21. Stricturing Crohn*s disease.
22. Any contraindication to oral feeding per se being: gastrointestinal failure
or suppressed gastrointestinal function, complete intestinal obstruction and
major intra-abdominal sepsis.
23. Investigator*s uncertainty about the willingness or ability of the subject
to comply with the protocol requirements, for example due to the presence of a
psychiatric disorder (e.g. major depression, psychoses), dementia or
Alzheimer*s disease.
24. Planned hospital admission during the study.
25. Planned dental surgery during the study.
26. Participation in any other studies involving investigational or marketed
products concomitantly or within 6 weeks prior to baseline.
27. Severe disease with life expectancy less than a year.
28. If the subject is unable to sign the Informed Consent themselves.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87452.056.24 |
| Other | Registratie in CT.gov volgt |