Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials.

Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m2, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any 'health' screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.

Demonstrating the safety of manuka honey UMF 20+in a human clinical trial with healthy individuals.

Honey is an established traditional medicine with a variety of putative nutritional and health effects, including antibacterial, antioxidant, anti-inflammatory and prebiotic. The aim of the present study was to investigate the safety of consuming manuka honey, UMF 20+, on healthy individuals by establishing whether UMF 20+caused an allergic response (as measured by IgE levels), changed major commensal and beneficial microbial groups in the gut and/or affected levels of one of the most common advanced glycation endpoints, N-(carboxymethyl)-lysine (CML). The study had a randomised, double-blind cross-over design. A total of twenty healthy individuals aged 42-64 years were recruited. We tested two different honeys- a multiflora honey and UMF 20+, both produced by Comvita New Zealand Ltd (Te Puke, New Zealand). Multiflora honey or UMF 20+(20 g) was consumed daily for 4 weeks, with a 2-week 'washout' period in between. Blood samples were collected every week for each intervention period and used to measure total IgE levels in serum and advanced glycation endproducts - a consequence of methyglyoxal accumulation. Faecal samples were collected at the beginning and end of each 4-week period. DNA was extracted from faecal samples and the levels of a number of microbial groups in the gut, both beneficial and commensal, were analysed. Neither product changed the levels of IgE or CML or altered gut microbial profiles during the trial, confirming that UMF 20+is safe for healthy individuals to consume. Despite anecdotal evidence suggesting that manuka honey is good for digestive health, we observed no beneficial effects on lower gut bacterial levels with either honey in this healthy population.

In vitro effects of food extracts on selected probiotic and pathogenic bacteria.

A panel of 148 extracts from 37 food products was prepared using organic and aqueous solvents and both neutral and acidic conditions. The panel of food products tested included fruits, vegetables, grains, herbs and spices, most of which are common in a normal European-style diet. The impact of these extracts on the growth of selected probiotic bacteria (Lactobacillus reuteri, Lactobacillus rhamnosus, Bifidobacteria lactis) and pathogenic bacteria (Escherichia coli 0157:H7 and Escherichia coli LF82) was assessed using a standard minimum inhibitory concentration method. The results showed that aqueous extractions of garlic and black peppercorns significantly enhanced the growth of one strain of probiotic bacteria (L. reuteri) whilst inhibiting both pathogenic strains of E. coli at a 1:50 dilution. Aqueous extracts of banana, apple and orange all enhanced the growth of the three probiotic strains significantly, and inhibited the pathogens to approximately 80% of the controls (not significant). Both aqueous and organic extractions of ginger significantly inhibited the growth of one or both E. coli strains, respectively (also at the 1:50 dilution).

Cecal and colonic responses in rats fed 5 or 30% corn oil diets containing either 7.5% broccoli dietary fiber or microcrystalline cellulose.

Growing evidence suggests that microbiota in the human gastrointestinal tract play a crucial role in mediating the effects of foods on colonic health and host metabolism. The large bowel ecosystem is known to be perturbed in humans and animals fed high-fat diets and conversely to be protected by fermentable oligosaccharides. We examined the ability of largely fermentable dietary fiber from broccoli ( Brassica oleracea L. var. italica ) and minimally fermented microcrystalline cellulose to buffer against the effects of high-fat intakes. The results showed that high fat lowered food intakes and therefore fiber intake by 27%. The addition of fermentable oligosaccharide to the diet was shown to be beneficial to some microbiota in cecum, altered cecal short-chain fatty acids, and increased the colon crypt depth and the number of goblet cells per crypt in high- and low-fat diets. Although, the fat level was the predominant factor in changes to the large bowel ecosystem, we have shown that broccoli fiber conferred some protection to consumption of a high-fat diet and particularly in terms of colon morphology.