High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study
ESPEN guidelines recommend a minimum protein intake of 1.0 g/kg body weight (BW) per day to maintain or restore lean body mass in patients with cancer. During anti-cancer treatment, optimal protein intake is difficult to achieve. We investigated whether a high-protein, low-volume oral nutritional su...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-12-01
|
| Series: | Nutrients |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-6643/15/24/5030 |
| _version_ | 1797379769244844032 |
|---|---|
| author | Anne-Marie Dingemans Nico van Walree Franz Schramel Magdolen Youssef-El Soud Edita Baltruškevičienė Willem Lybaert Margriet Veldhorst Claudia. A. van den Berg Stein Kaasa |
| author_facet | Anne-Marie Dingemans Nico van Walree Franz Schramel Magdolen Youssef-El Soud Edita Baltruškevičienė Willem Lybaert Margriet Veldhorst Claudia. A. van den Berg Stein Kaasa |
| author_sort | Anne-Marie Dingemans |
| collection | DOAJ |
| description | ESPEN guidelines recommend a minimum protein intake of 1.0 g/kg body weight (BW) per day to maintain or restore lean body mass in patients with cancer. During anti-cancer treatment, optimal protein intake is difficult to achieve. We investigated whether a high-protein, low-volume oral nutritional supplement (ONS) supports patients in meeting recommendations. A multi-centre, randomised, controlled, open-label, parallel-group study was carried out in nine hospitals (five countries) between January 2019 and July 2021 in colorectal and lung cancer patients undergoing first-line systemic treatment with chemo(radio-) or immunotherapy. Subjects were randomised (2:1) to receive Fortimel Compact Protein<sup>®</sup> or standard care. Protein intake was assessed with a 3-day food diary (primary outcome). BW was a secondary outcome. Due to challenges in recruitment, the study was terminated prematurely with 42 patients randomised (intervention group (IG) 28; control group (CG) 14). At T1 and T2, protein intake was statistically significantly higher in the IG compared to the CG (1.40 vs. 1.07 g/kg/day at T1, <i>p</i> = 0.008; 1.32 vs. 0.94 g/kg/day at T2, <i>p</i> = 0.002). At baseline, only 65% (IG) and 45% (CG) of patients met ESPEN minimum protein intake recommendations. However, at T1 and T2 in the IG, a higher proportion of patients met recommendations than in the CG (88% vs. 55% and 40%). No statistically significant difference between study groups was observed for BW. Mean compliance to the ONS was 73.4%. A high-protein, low-volume ONS consumed twice daily enables the majority of patients to reach minimal ESPEN protein recommendations. |
| first_indexed | 2024-03-08T20:27:48Z |
| format | Article |
| id | doaj.art-3c13d37bcbe947eeb86c9459c9642aba |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-08T20:27:48Z |
| publishDate | 2023-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-3c13d37bcbe947eeb86c9459c9642aba2023-12-22T14:29:53ZengMDPI AGNutrients2072-66432023-12-011524503010.3390/nu15245030High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group StudyAnne-Marie Dingemans0Nico van Walree1Franz Schramel2Magdolen Youssef-El Soud3Edita Baltruškevičienė4Willem Lybaert5Margriet Veldhorst6Claudia. A. van den Berg7Stein Kaasa8Department of Pulmonology, Erasmus Medical Center Cancer Institute, 3015 CN Rotterdam, The NetherlandsDepartment of Pulmonary Diseases, Amphia Hospital, 4818 CK Breda, The NetherlandsDepartment of Pulmonary Diseases, St. Antonius Hospital, 3435 CM Nieuwegein, The NetherlandsDepartment of Pulmonary Diseases, Máxima Medisch Centrum, 5504 DB Veldhoven, The NetherlandsDepartment of Medical Oncology, National Cancer Institute, 08406 Vilnius, LithuaniaDepartment of Medical Oncology, VITAZ, 9100 Sint-Niklaas, BelgiumNutricia Research, 3584 CT Utrecht, The NetherlandsNutricia Research, 3584 CT Utrecht, The NetherlandsDepartment of Oncology, Oslo University Hospital, 0379 Oslo, NorwayESPEN guidelines recommend a minimum protein intake of 1.0 g/kg body weight (BW) per day to maintain or restore lean body mass in patients with cancer. During anti-cancer treatment, optimal protein intake is difficult to achieve. We investigated whether a high-protein, low-volume oral nutritional supplement (ONS) supports patients in meeting recommendations. A multi-centre, randomised, controlled, open-label, parallel-group study was carried out in nine hospitals (five countries) between January 2019 and July 2021 in colorectal and lung cancer patients undergoing first-line systemic treatment with chemo(radio-) or immunotherapy. Subjects were randomised (2:1) to receive Fortimel Compact Protein<sup>®</sup> or standard care. Protein intake was assessed with a 3-day food diary (primary outcome). BW was a secondary outcome. Due to challenges in recruitment, the study was terminated prematurely with 42 patients randomised (intervention group (IG) 28; control group (CG) 14). At T1 and T2, protein intake was statistically significantly higher in the IG compared to the CG (1.40 vs. 1.07 g/kg/day at T1, <i>p</i> = 0.008; 1.32 vs. 0.94 g/kg/day at T2, <i>p</i> = 0.002). At baseline, only 65% (IG) and 45% (CG) of patients met ESPEN minimum protein intake recommendations. However, at T1 and T2 in the IG, a higher proportion of patients met recommendations than in the CG (88% vs. 55% and 40%). No statistically significant difference between study groups was observed for BW. Mean compliance to the ONS was 73.4%. A high-protein, low-volume ONS consumed twice daily enables the majority of patients to reach minimal ESPEN protein recommendations.https://www.mdpi.com/2072-6643/15/24/5030oral nutritional supplementshigh proteinnutrition supportcancermalnutrition |
| spellingShingle | Anne-Marie Dingemans Nico van Walree Franz Schramel Magdolen Youssef-El Soud Edita Baltruškevičienė Willem Lybaert Margriet Veldhorst Claudia. A. van den Berg Stein Kaasa High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study Nutrients oral nutritional supplements high protein nutrition support cancer malnutrition |
| title | High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study |
| title_full | High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study |
| title_fullStr | High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study |
| title_full_unstemmed | High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study |
| title_short | High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study |
| title_sort | high protein oral nutritional supplements enable the majority of cancer patients to meet protein intake recommendations during systemic anti cancer treatment a randomised controlled parallel group study |
| topic | oral nutritional supplements high protein nutrition support cancer malnutrition |
| url | https://www.mdpi.com/2072-6643/15/24/5030 |
| work_keys_str_mv | AT annemariedingemans highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT nicovanwalree highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT franzschramel highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT magdolenyoussefelsoud highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT editabaltruskeviciene highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT willemlybaert highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT margrietveldhorst highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT claudiaavandenberg highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy AT steinkaasa highproteinoralnutritionalsupplementsenablethemajorityofcancerpatientstomeetproteinintakerecommendationsduringsystemicanticancertreatmentarandomisedcontrolledparallelgroupstudy |