Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia (ApoCarb)

University of Copenhagen

Status: Completed

Conditions: Apoplexy; Brain

Treatments: Dietary Supplement: Carbloading and maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04688489

H-20018258

Details and patient eligibility

About

The study will investigate the potential effect of a supplement of maltodextrin and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Besides the primary outcome there are several secondary outcomes (see detailed description). All patients are recruited from Rigshospitalet, Glostrup.

Full description

The study will investigate the potential effect of a supplement of maltodextrin (20 g for women and 30 g for men) and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Secondary outcomes are: training intensity, duration and frequency; length of stay; self-training (training without a therapist) and patient's experienced fatigue; and patient's experienced pain. All patients are recruited from Rigshospitalet, Glostrup. The supplement will be administered before and after each training session with a therapist. The supplement is a powder desolved in a glass of juice. The nursing staff will add extra carbohydrates to the patient's meals in the form of potatoes, rice, bread, fruit or other carbohydrate rich food items. All meals will be noted daily and validated the following day by the primary investigators.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with apoplexia who are declared suited for rehabilitation at Afs. Neurologisk Afdeling N 35 - Apopleksi or Afs. Neurologisk Afdeling N 45 - Apopleksi, Rigshospitalet, Glostrup
• Patient must be able to consent participation
• Age 50+ years
• Must be able to understand danish
• Must be relevant for physio- or occupational therapy

Exclusion criteria

• Diabetes Mellitus type I og type II
• Enteral nutrition (tube feeding)
• Barthel-100 over 80 points

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Intervention

Active Comparator group

Description:

The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals

Treatment:

Dietary Supplement: Carbloading and maltodextrin

Control

No Intervention group

Description:

The control receives no intervention. Standard treatment will be administered.