A Randomized Controlled Trial on the Effects of Leucine-Supplement Combined with Nutritional Counseling on Body Composition in Mix Cancer Older Men.
Study Goal
The researchers aimed to evaluate the effect of leucine supplementation on body composition in male outpatients with gastrointestinal tract cancer undergoing chemotherapy.
Results Summary
Leucine supplementation led to significant gains in body weight, BMI, fat-free mass (FFM), and appendicular skeletal muscle mass (ASMM) in the intervention group, though no significant intergroup differences were detected. The results were similar among cachectic patients, but the study noted uncertainty about whether the muscle mass increase was due to leucine or overall adequate calorie and macronutrient intake.
Population
Older men diagnosed with gastrointestinal and appendix organ cancers undergoing chemotherapy.
Effective Dosage
Not specified
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
L-leucine supplement | increase | body weight | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy who finished all the supplementation | 61.79.9 ± 9.02 versus 64.06 ± 9.45 | significant gain | #1 |
L-leucine supplement | increase | ASMM | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy who finished all the supplementation | 7.64 ± 1.24 versus 7.81 ± 1.20 | significant gain | #2 |
L-leucine supplement | increase | body weight | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy included in the intention-to-treat analysis | - | significant increase | #3 |
L-leucine supplement | increase | BMI | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy included in the intention-to-treat analysis | - | significant increase | #4 |
L-leucine supplement | increase | FFM | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy included in the intention-to-treat analysis | - | significant increase | #5 |
L-leucine supplement | increase | ASMM | male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy included in the intention-to-treat analysis | - | significant increase | #6 |
balanced diet enriched with free-Leucine supplementation | increase | body weight | older men diagnosticated with gastrointestinal and appendix organs of digestion cancer | - | promotes gains | #7 |
balanced diet enriched with free-Leucine supplementation | increase | lean mass | older men diagnosticated with gastrointestinal and appendix organs of digestion cancer | - | promotes gains | #8 |
BACKGROUND: Malnutrition and metabolic alterations of cancer cachexia are often associated with negative weight loss and muscle mass wasting. In this sense, protein supplementation can be a strategy to help counteract the loss and/or maintenance of mass in these patients. The aim of this study was to evaluate the effect of leucine supplementation on body composition in outpatients with gastrointestinal tract cancer. METHODS: It was a randomized, blinded, controlled, parallel trial, performed in male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy. All the patients were allocated to one of the protocol groups: L-leucine supplement or the control group, during 8 weeks of intervention. We evaluated the body composition through bioelectrical impedance analysis, the cancer cachexia classification, and the diet intake before and after the intervention protocol. The intention-to-treat approach was performed to predict the missing values for all patients who provide any observation data. RESULTS: The patients were an average age of 65.11 ± 7.50 years old. In the body composition analysis with patients who finished all the supplementation, we observed a significant gain in body weight (61.79.9 ± 9.02 versus 64.06 ± 9.45, p = 0.01), ASMM (7.64 ± 1.24 versus 7.81 ± 1.20, p = 0.02) in the Leucine group, whereas patients in the control did not present significant variation in these parameters. There was no significant intergroup difference. While in the analysis included the patients with intention-to-treat, we found a significant increase in body weight (p = 0.01), BMI (p = 0.01), FFM (p = 0.03), and ASMM (p = 0.01) in the Leucine group. No significant intergroup differences. These results also similar among cachectic patients. CONCLUSION: A balanced diet enriched with free-Leucine supplementation was able to promotes gains in body weight and lean mass in older men diagnosticated with gastrointestinal and appendix organs of digestion cancer after 8 weeks. However, the fact that most men are non-cachectic or pre-cachectic is not clear if the increase in muscle mass was due to a high intake of leucine, since no difference between groups was detected. Moreover, we know that benefits on body composition are due to adequate calorie and macronutrients consumption and that balanced feeding according to nutrition Guidelines seems crucial and must be advised during the oncological treatment.