To investigate the effect of PB HEHP ONS compared to DB HEHP ONS on nutritional intake (energy & protein) in subjects with or at risk of DRM and/or prescribed with ONS.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Ziekte gerelateerde ondervoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome of the study:
To investigate the effect of PB HEHP ONS compared to DB HEHP ONS on nutritional
intake (energy & protein) in subjects with or at risk of Disease Related
Malnutrition (DRM) and/or prescribed with ONS.*
Secondary outcome
other outcomes of the study:
To investigate the effect of PB HEHP ONS compared to DB HEHP ONS in subjects
with or at risk of DRM and/or prescribed with ONS prior to the study on:*
- Safety and gastrointestinal (GI) tolerance*
- Compliance**
- Product experience & liking*
- Changes in anthropometry (BW, BMI)*
- Changes in blood nutrient status (Vitamin D (25(OH)D), ferritin, zinc,
calcium, parathyroid hormone (PTH)*
- Changes in percentage of subjects with or at risk of malnutrition according
to the Malnutrition Universal Screening Tool (MUST).*
- Changes in health-related quality of life (QoL) (EQ-5D-5L)*
- Changes in muscle strength & function (Hand Grip Strength & x 5 sit to stand
test).**
Background summary
The World Health Organization (WHO) reports the global prevalence of
malnutrition showing that 462 million adults and about 2 billion people are
underweight and suffer from micronutrient deficiency, respectively. According
to the Medical Nutrition International Industry dossier the estimated number of
people suffering from malnutrition in Europe is 33 million (MNI 2018). The
prevalence of malnutrition can be associated with specific groups of disease
and settings of care. Disease related malnutrition (DRM) is the consequence of
inadequate dietary intake and nutritional support, and it can negatively impact
the recovery of patients. Oral nutritional supplements (ONS) have proven
clinical benefits for malnourished patients: ONS use is linked to lower
mortality and lower complication rates when compared to standard of care.
Historically, most ONS are made with dairy proteins, however, as more people
transition to PB diets and the demand for products that do not contain animal
derived ingredients grows, there is a growing request for PB ONS to meet this
unmet need. Currently there are some PB ONS on the market, but very few that
are high in energy and high in protein, and ready to drink. There is also very
little evidence currently on plant based medical nutrition.*
Study objective
To investigate the effect of PB HEHP ONS compared to DB HEHP ONS on nutritional
intake (energy & protein) in subjects with or at risk of DRM and/or prescribed
with ONS.
Study design
This is a randomised controlled, double blind, parallel-group, multi-centre,
multi-country, exploratory study.
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 8
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 (3x) and phone calls (2x) is limited . In consultation and if the site
can facilitate (i.e. mobile blood collection), 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. Age >= 18 years
2.Identified as at medium or high risk of malnutrition based on:
a) MUST score >= 1 and / or b)Being prescribed with ONS and willing and able to
switch from pre-study prescribed ONS to the Test or Control Product for
participation in the study
3. In need of 2 servings of ONS/day (400 kcal; 20 gr protein per serving) for
at least 8 weeks as determined by the treating healthcare professional.
4. Medically and physically able to consume high energy high protein ONS in the
opinion of the Investigator.
5. Willing to maintain dietary habits for the duration of the study.
6. Willing to consume plant based as well as dairy based ONS.
Exclusion criteria
1. Known allergy to soy, cow*s milk protein or to any other ingredients as
listed in the study product composition (refer to the product information
brochure (PIB) and the appendix of this protocol).
2. Known intolerance to any ingredients as listed in the study product
composition (refer to PIB and appendix of this protocol). Subjects with lactose
intolerance who use lactase may still be enrolled in the study.
3. Known galactosaemia
4. Any contraindication to oral feeding per se being: gastrointestinal failure
or suppressed gastrointestinal function, complete intestinal obstruction and
major intra-abdominal sepsis.
5. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw
Index (HBI) >6 (Crohn*s disease) or Simple Clinical Colitis Activity Index
(SCCAI) >5 (ulcerative colitis).
6. Recent history of gastrointestinal surgery (except appendectomy) that
interferes with the GI function, e.g. ileostomy, colostomy, (partial)
gastrectomy or any other procedure for stomach volume reduction including
gastric banding, within four weeks prior to the screening visit.
7. Requiring a protein restricted diet as confirmed by a physician, for example
chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate
<30 mL/min/1.73 m2).
8. End stage renal disease (with renal replacement therapy e.g. haemodialysis
or peritoneal dialysis), who may not require protein restriction.
9. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
Design
Recruitment
Medical products/devices used
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 | NL87757.056.24 |
| Other | Registratie in Clintrials.gov database volgt |