Effects of 3 months of multi-nutrient supplementation on the immune system and muscle and respiratory function of older adults in aged care (The Pomerium Study): protocol for a randomised controlled trial.

INTRODUCTION: Immunosenescence leads to increased morbidity and mortality associated with viral infections and weaker vaccine responses. This has been well documented for seasonal influenza and the current pandemic with SARS-CoV-2 (COVID-19), which disproportionately impact older adults, particularly those in residential aged care facilities. Inadequate nutrient intakes associated with impaired immunity, respiratory and muscle function are likely to augment the effects of immunosenescence. In this study, we test whether the impact of inadequate nutrition can be reversed using multi-nutrient supplementation, consequently enhancing vaccine responses, reducing the risk of viral infections and improving respiratory and muscle function. METHODS AND ANALYSIS: The Pomerium Study is a 3-month, single-blind, randomised, controlled trial testing the effects of two daily servings of an oral multi-nutrient supplement (330 kcal, 20 g protein, 1.5 g calcium 3-hydroxy-3-methylbutyrate monohydrate (CaHMB), 449 mg calcium, 500 IU vitamin D3 and 25 vitamins and minerals) on the immune system and muscle and respiratory function of older adults in aged care in Melbourne, Australia. 160 older adults (≥75 years old) will be recruited from aged care facilities and randomised to treatment (multi-nutrient supplement) or control (usual care). The primary outcome is a change in T-cell subsets CD8 + and CD28null counts at months 1 and 3. Secondary outcomes measured at baseline and month 3 are multiple markers of immunosenescence (also at 1 month), body composition (bioimpedance), handgrip strength (dynamometer), physical function (short physical performance battery), respiratory function (spirometry) and quality of life (EQ-5D-5L). Incidence and complications of COVID-19 and/or viral infections (ie, hospitalisation, complications or death) will be recorded throughout the trial, including 3 months after supplementation is ceased. ETHICS AND DISSEMINATION: This study was approved by Melbourne Health Human Research Ethics Committee (Ref No. HREC/73985/MH-2021, ERM Ref No. RMH73985, Melbourne Health Site Ref No. 2021.115). Written informed consent will be obtained from participants. Results will be published in peer-reviewed journals and made available to key aged care stakeholders, including providers, residents, and government bodies. TRIAL REGISTRATION NUMBER: ACTRN12621000420842.

Serum zonulin measured by enzyme-linked immunosorbent assay may not be a reliable marker of small intestinal permeability in healthy adults.

The association between intestinal permeability (IP) and body composition remains unclear. The gold standard differential sugar-absorption test is arduous to complete, with zonulin being increasingly used as an independent biomarker of IP. This pilot study aimed to explore the association between small IP, zonulin concentrations, and body composition in healthy adults. The urinary lactulose-rhamnose ratio was used to measure small IP. Serum zonulin, lipopolysaccharide (LPS) and high-sensitivity C-reactive protein (hs-CRP) were analyzed in serum. Body composition was measured using dual-energy X-ray absorptiometry and anthropometric measurements were collected. In total, 34 participants were included (12 males, median age 28 years, body mass index 24 kg/m2, waist circumference 77cm). No correlation was observed between the lactulose-rhamnose ratio and zonulin (r = -.016, P = .929). The lactulose-rhamnose ratio displayed a strong positive correlation with LPS (n 20, r = .536, P = .018) but did not correlate with body composition measures. Conversely, zonulin displayed a moderate positive correlation with waist circumference (r = .437, P = .042) in female participants and hs-CRP (r = .485, P = .004) in all participants. These findings raise important considerations for the measurement of small IP, warranting exploration in larger powered studies that address the limitations of the present study.

Quinoa Seed Lowers Serum Triglycerides in Overweight and Obese Subjects: A Dose-Response Randomized Controlled Clinical Trial.

Background: Quinoa (Chenopodium quinoa) is a pseudo-cereal originally cultivated in the Andean region. The popularity of its seeds has increased in recent years due to the claims of health benefits and superfood qualities. Studies to date on the health benefits of quinoa have been restricted to animal models, and the results provide weak to moderate evidence to support improved plasma lipid profiles. Clinical trials in humans to examine the claims of health benefits of quinoa are limited to a few prospective studies and one randomized trial carried out in postmenopausal women. To our knowledge, no studies have been conducted in the general population. Objective: The objective of this randomized clinical trial was to investigate the effect of different quinoa doses (25 and 50 g/d) on body composition, serum lipids and hormones, and nutrient intakes in overweight and obese humans. Methods: This was a dose-response randomized, controlled, single-blind trial with a parallel design (1 control and 2 treatment groups) that compared the effect of 25 and 50 g quinoa/d in 50 overweight and obese participants over a 12-wk intervention period. Results: Body composition, nutrient intake, and total, LDL, and HDL cholesterol were not significantly altered by quinoa consumption (P > 0.05). Mean serum triglyceride (TG) concentration was reduced significantly in the 50-g quinoa group from 1.14 to 0.72 mmol/L at 12 wk (P < 0.05). The prevalence of metabolic syndrome (MetS) was also reduced in this group by 70%. No significant changes in TGs were observed in the control and 25-g quinoa groups. The prevalence of MetS was reduced by 40% (from n = 7 at baseline to n = 4 at 12 wk) in the 25-g group. Conclusions: The consumption of 50 g quinoa/d lowers serum TGs in overweight and obese participants and reduces the prevalence of MetS. This trial was registered at clinicaltrials.gov as UTN U1111-1175-470.