Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants' gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: n = 149, CF: n = 148) and 41 BF infants completed the study per protocol. All tolerance parameters were comparable between eHF and CF. Stool was predominantly soft and yellow in colour. Stool was more frequently green in eHF than CF. BF infants had more frequent stools, which were mainly watery or soft and yellow, and comparable IGSQ scores (descriptive). Irrespective of group, all gastrointestinal and sleep parameters showed signs of maturation with increasing age. In conclusion, eHF showed gastrointestinal tolerance as good as CF in healthy infants. Both formulae were well-tolerated.

Correction: Otten et al. Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants. Nutrients 2023, 15, 1901.

In the original publication [...].

Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

We aimed to demonstrate that healthy term infants experience noninferior growth with infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF). This prospective, randomised, double-blind, parallel-group, controlled, multicentre trial included healthy term infants who were exclusively formula-fed. Infants ≤ 25 days of age received eHF or CF for at least three months up to 120 days of age, with a follow-up until 180 days of age. A reference group included exclusively breastfed infants (BF). Of 318 infants randomised, 297 (148 CF, 149 eHF) completed the study per protocol. Weight gain up to 120 days of age was noninferior (margin -3.0 g/day) in eHF (28.95 (95% CI: 27.21; 30.68) g/day) compared to CF (28.85 (95% CI: 27.10; 30.61) g/day) with a difference in means of 0.09 g/day and a lower limit of the one-sided 97.5% CI of -0.86 g/day (p < 0.0001 for noninferiority testing). Weight gain remained comparable during follow-up. Further anthropometric parameters did not differ between the infant formula groups throughout the study. Growth was comparable in BF. No relevant safety issues were observed. To conclude, eHF meets infant requirements for adequate growth during the first six months of life and can be considered safe and suitable.

Associations Between Serum GDF15 Concentrations, Muscle Mass, and Strength Show Sex-Specific Differences in Older Hospital Patients.

Aging is accompanied by a progressive decline of muscle mass and strength and also higher levels of circulating cytokines such as growth differentiation factor 15 (GDF15). Studies evaluating the association of GDF15 with muscle mass and strength are rare. In this analysis, we investigated GDF15 concentrations and their relationship with muscle mass and strength in older men compared with women. GDF15 serum concentrations were measured in 103 (60 years and older) hospital patients and an age-matched control group with an immunosorbent assay. Skeletal muscle mass was determined with the bioelectrical impedance analysis. Grip strength and knee extension strength were assessed and normalized for height. Associations between GDF15 concentrations and muscle mass and strength were evaluated with general linear models. Male patients showed higher levels of GDF15 compared with female patients (p = 0.021). Elevated GDF15 concentrations were associated with lower measures of muscle mass, exclusively in men, after adjustment for age and number of drugs per day. Our results indicate sex differences between associations of GDF15 with muscle mass and strength parameters in a cohort of older hospital patients.

Severe Weight Loss and Its Association with Fatigue in Old Patients at Discharge from a Geriatric Hospital.

Although malnutrition is frequent in the old, little is known about its association with fatigue. We evaluated the relation of self-reported severe weight loss with fatigue and the predictors for fatigue in old patients at hospital discharge. Severe weight loss was defined according to involuntary weight loss ≥5% in the last three months. We determined fatigue with the validated Brief Fatigue Inventory questionnaire. The regression analyses were adjusted for age, sex, number of comorbidities, medications/day, and BMI. Of 424 patients aged between 61 and 98 y, 34.1% had severe weight loss. Fatigue was higher in patients with severe weight loss (3.7 ± 2.3 vs. 3.2 ± 2.3 points, p = 0.021). In a multinomial regression model, weight loss was independently associated with higher risk for moderate fatigue (OR:1.172, CI:1.026-1.338, p = 0.019) and with increased risk for severe fatigue (OR:1.209, CI:1.047-1.395, p = 0.010) together with the number of medications/day (OR:1.220, CI:1.023-1.455, p = 0.027). In a binary regression model, severe weight loss predicted moderate-to-severe fatigue in the study population (OR:1.651, CI:1.052-2.590, p = 0.029). In summary, patients with self-reported severe weight loss at hospital discharge exhibited higher fatigue levels and severe weight loss was an independent predictor of moderate and severe fatigue, placing these patients at risk for impaired outcome in the post-hospital period.

Higher serum levels of fibroblast growth factor 21 in old patients with cachexia.

OBJECTIVE: Fibroblast growth factor (FGF)21 is promptly induced by short fasting in animal models to regulate glucose and fat metabolism. Data on FGF21 in humans are inconsistent and FGF21 has not yet been investigated in old patients with cachexia, a complex syndrome characterized by inflammation and weight loss. The aim of this study was to explore the association of FGF21 with cachexia in old patients compared with their healthy counterparts. METHODS: Serum FGF21 and its inactivating enzyme fibroblast activation protein (FAP)-α were measured with enzyme-linked immunoassays. Cachexia was defined as ≥5% weight loss in the previous 3 mo and concurrent anorexia (Council on Nutrition appetite questionnaire). RESULTS: We included 103 patients with and without cachexia (76.9 ± 5.2 y of age) and 56 healthy controls (72.9 ± 5.9 y of age). Cachexia was present in 16.5% of patients. These patients had significantly higher total FGF21 levels than controls (952.1 ± 821.3 versus 525.2 ± 560.3 pg/mL; P = 0.012) and the lowest FGF21 levels (293.3 ± 150.9 pg/mL) were found in the control group (global P < 0.001). Although FAP-α did not differ between the three groups (global P = 0.082), bioactive FGF21 was significantly higher in patients with cachexia (global P = 0.002). Risk factor-adjusted regression analyses revealed a significant association between cachexia and total (ß = 649.745 pg/mL; P < 0.001) and bioactive FGF21 (ß = 393.200 pg/mL; P <0.001), independent of sex, age, and body mass index. CONCLUSIONS: Patients with cachexia exhibited the highest FGF21 levels. Clarification is needed to determine whether this is an adaptive response to nutrient deprivation in disease-related cachexia or whether the increased FGF21 values contribute to the catabolic state.

Impact of sarcopenia on 1-year mortality in older patients with cancer.

OBJECTIVES: sarcopenia is common especially in hospitalised older populations. The aim of this study was to assess the prevalence of sarcopenia, defined as low skeletal mass and muscle strength, and its impact on 1-year mortality in older patients with cancer. METHODS: skeletal muscle mass was estimated using bioelectric impedance analysis and related to height2 (SMI; Janssen et al. 2002). Grip strength was measured with the JAMAR dynamometer and the cut-offs suggested by the European Working Group on Sarcopenia in Older People (EWGSOP) were applied. One-year mortality was assessed by telephone follow-up and the local cancer death registry. RESULTS: of the 439 consecutively recruited cancer patients (60-95 years; 43.5% women), 119 (27.1%) had sarcopenia. Of the patients with sarcopenia, 62 (52.5%) died within 1 year after study entry compared to 108 (35.1%) patients who did not have sarcopenia (P = 0.001). In a stepwise, forward Cox proportional hazards analysis, sarcopenia (HR = 1.53; 95% CI: 1.034-2.250; P < 0.05), advanced disease (HR = 1.87; 95% CI: 1.228-2.847; P < 0.05), number of drugs/day (HR = 1.11; 95% CI: 1.057-1.170; P < 0.001), tumour diagnosis (overall P < 0.05) and Karnofsky index (HR = 0.98, 95% CI: 0.963-0.995; P < 0.05) associated with 1-year mortality risk. The factors sex, age, co-morbidities and involuntary 6-month weight loss ≥5% were insignificant. CONCLUSIONS: sarcopenia was present in 27.1% of older patients with cancer and was independently associated with 1-year mortality. The fact that sarcopenia was nearly as predictive for 1-year mortality as an advanced disease stage underlines the importance of preservation of muscle mass and function as a potential target of intervention in older patients with cancer.

Financial impact of sarcopenia or low muscle mass - A short review.

BACKGROUND & AIMS: Low muscle mass is associated with increased falls, medical complications, length of hospital stay and loss of independence. An increasing number of studies has also shown the association between sarcopenia and health care expenditure. The following narrative review summarizes the current evidence on the economic relevance of low muscle mass (MM) or sarcopenia. METHODS: An extensive search of the literature in Medline identified twelve studies in English, which evaluated direct and indirect health care expenditure in patients with low muscle mass or sarcopenia (low MM and strength or mobility). RESULTS: Three studies analysed the cost of age-related loss of MM or strength in large surveys of the general, older population. Six retrospective analyses evaluated perioperative medical costs related to low MM in primarily older patients from different medical areas. One prospective study presented hospital costs related to sarcopenia in patients with gastric cancer. Two studies presented data from general hospital patients. Despite the difference in diagnostic criteria, study population and statistical design, low MM and sarcopenia were consistently identified as predictors of increased health care expenditure in community, perioperative and general hospital settings. CONCLUSIONS: Low MM and sarcopenia are prevalent and associated with significantly higher health care costs. Considering the demographic change, which will lead to an increasing number of patients with sarcopenia, every effort should be made to identify and treat patients with sarcopenia. The use of a unified definition and diagnostic criteria would allow a better comparison of data.

Prevalence of sarcopenia in systemic sclerosis: assessing body composition and functional disability in patients with systemic sclerosis.

OBJECTIVE: We analyzed the prevalence of sarcopenia among systemic sclerosis (SSc) patients with respect to quality of life, disability, organ involvement, and muscle function. METHODS: A total of 129 patients who met the ACR/EULAR 2013 classification criteria were included. Body composition was measured using bioelectric impedance analysis. Sarcopenia was defined according to the criteria of the European Working Group on Sarcopenia in Older People. Handgrip and knee extension strength and pulmonary peak flow were measured. Physical function was assessed with the Short Form-36 Health Survey and Scleroderma Health Assessment Questionnaire. RESULTS: Sarcopenia was prevalent in 22.5% of patients. There were significant differences between patients with and without sarcopenia regarding handgrip strength (11.5 [2.0-30.0] versus 18.0 [1.0-41.0] kilogram force [kgf]; P <0.001) and knee extension strength (11.0 [3.5-32.5] versus 17.5 [3.5-88.0] kgf; P = 0.006), physical function (38.8 [9.9-85.0] versus 48.8 [0-88.0]; P = 0.032) and number of immunosuppressants (2 [0-4] versus 1 [0-5]; P = 0.009). There were no differences regarding age (57.0 [32.0-83.0] versus 60.5 [28.0-82.0] years; P = 0.350) and disease duration (8 [1-27] versus 7 [0-34] years; P = 0.350). CONCLUSIONS: Sarcopenia is common in patients with SSc and is associated with physical impairment that affects everyday life and participation in work. Interestingly, although age is the main risk factor for sarcopenia in the general population, it did not differ between sarcopenic and non-sarcopenic SSc patients in our study. Instead, the number of immunosuppressive drugs was significantly higher among sarcopenic patients.

Adherence to a Mediterranean-Style Diet and Appendicular Lean Mass in Community-Dwelling Older People: Results From the Berlin Aging Study II.

BACKGROUND: Selected nutrients or food groups have often been studied with regard to long-term mortality and cardiovascular disease, whereas the relation between diet quality and appendicular lean mass (ALM) has rarely been researched. OBJECTIVE: The aim of this study was to explore the association between a Mediterranean-style diet and ALM in community-dwelling older people. METHODS: Cross-sectional data from the Berlin Aging Study II were available for 1,509 participants (51% women, 68.2±3.7 years). Nutrient intake was assessed using the European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire. Adherence to a Mediterranean-style diet was evaluated with the modified Mediterranean-type diet score (mMedTypeDiet). ALM was determined by dual-energy X-ray absorptiometry and related to body mass index (ALM/BMI). A general linear regression model was carried out to assess the association between mMedTypeDiet score groups and ALM/BMI. RESULTS: ALM/BMI was higher in women with a higher adherence to the mMedTypeDiet (0.64±0.1 vs 0.62±0.1 and 0.61±0.1 in low and medium adherence, retrospectively, p = .004). In the risk factor-adjusted general linear regression analysis, a higher adherence to the mMedTypeDiet was associated with higher ALM/BMI in women and better ALM/fat mass ratio when compared to a medium and a low diet quality. No significant associations were seen in men. CONCLUSIONS: Higher adherence to a Mediterranean-style diet was associated with a positive effect on ALM/BMI in women.