## Protocol Section
### Identification Module
**NCT ID:** NCT02029079

**Brief Title:** The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition

**Official Title:** The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition

#### Organization Study ID Info
**ID:** 2013/962
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-01-13

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-01-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-08

**Status Verified Date:** 2014-01

#### Study First Post Date
**Date:** 2014-01-07
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-18
**Study First Submit QC Date:** 2014-01-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Haukeland University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished

The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.

**Detailed Description:** Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome.

Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community.

The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements.

The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.

### Conditions Module

**Conditions:**

- Malnutrition

**Keywords:**

- Malnutrition

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention consists of 300 ml E+ per day for 35 days in addition to a normal food intake. This means 525 kcal, and 22.5 gram protein extra per day for five weeks.

**Intervention Names:**

- Dietary Supplement: E+

**Label:** E+ drink, enriched with energy and nutrients.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects in the control group will be assessed in the same way and same time as the intervention group.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- E+ drink, enriched with energy and nutrients.

**Description:** 300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.

**Name:** E+

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial.

**Measure:** Change in Hand grip strength

**Time Frame:** Assessment at day 0, 35 and 70.

**Description:** Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales.

**Measure:** Change in Body weight

**Time Frame:** At day 0, 35 and 70

**Description:** A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals.

**Measure:** Change in Body composition

**Time Frame:** At day 0, 35 and 70

#### Secondary Outcomes

**Description:** Dietary intake will be assessed for each study participant using a twenty-four-hour recall method conducted by the investigator and two additional people employed to help with the data collection. All three data collectors will use a standardized interview. The data collected will be used to calculate daily calorie and protein intake by entering the food records into a computerized version of a food composition table, Dietist XP.

**Measure:** Change in Nutritional intake

**Time Frame:** At day 0, 35 and 70

**Description:** Measurements of global subjective well-being and quality of life will be assessed using a simple visual analogue scale (VAS QL).

**Measure:** Change in Quality of life

**Time Frame:** At day 0, 35 and 70

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Recipients of homecare services in the municipality of Bergen
* Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment)
* Informed consent by participant
* Informed consent by participants and close relatives or guardian in case of dementia

Exclusion Criteria:

* Terminal care patients with \< 3 month life expectancy
* Patients using parenteral or enteral nutrition
* Patients prescribed oral nutritional supplementation before recruitment
* Pregnancy
* Diabetes Mellitus
* Lactose intolerance
* Patients without a norwegian personal identification number
* Psychiatric patients

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bergen

**Country:** Norway

**Facility:** Home Care Services

**Zip:** 5000

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Dietitian at Haukeland University Hospital

**Name:** Randi J Tangvik, PhD-student

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25306

- Name: Malnutrition

- Relevance: HIGH

- As Found: Malnutrition

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000044342

- Term: Malnutrition

### Misc Info Module

- Version Holder: 2024-05-24
