[Show abstract][Hide abstract] ABSTRACT: Rotavirus (RV) is a leading cause of morbidity and mortality in children under 5-yrs, presenting commonly with diarrhoeal symptoms. In a prospective 12-wk double-blind randomised controlled trial we assessed acceptability and efficacy of a high-ganglioside complex milk lipid (CML) for prevention of RV infection in 450 infants, aged 8-24 months, at 3 sites in Northern India. Prevalence of diarrhoea and RV was unseasonably low at baseline (all-cause diarrhoea, ACD, n = 16; RV-diarrhoea, RVD, n = 2; RV infection, RV, n = 20) and throughout the trial, with only 110 total episodes of ACD over 12-wks (CML, n = 62; Control, n = 48) of which 10 were RVD (CML, n = 4; Control, n = 6). Mean duration that RVD persisted was lower in the CML (2.3 ± 0.5 days) group than Control (3.8 ± 1.3 days, P = 0.03), but only 3 of 450 end of trial stool samples were identified as RV (<1%; CML, n = 2; Control, n = 1). This hampered the assessment of efficacy of CML, despite the large a priori determined sample size. During the trial similar numbers of infants reported adverse events (AEs: CML = 41%, Control = 46%), with the majority of events classified as mild and not related to the intervention. In conclusion, further clinical trials aginst a higher background of seasonal prevalence are necessary to assess efficacy of this nutritional intervention to prevent RVD. Importantly, however, high-ganglioside CML was acceptable for long-term consumption in infants aged 8-24 months.
Journal of pediatric gastroenterology and nutrition 04/2014; DOI:10.1097/MPG.0000000000000398 · 2.63 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Previous laboratory studies have identified two dairy fractions, glycomacropeptide (GMP) and G600 milk fat extract (G600), with anti-inflammatory effects in models of acute gout. The aim of this proof-of-concept clinical trial was to test the hypothesis that daily intake of skim milk powder (SMP) enriched with GMP and G600 can prevent gout flares.
This was a 3-month randomised double-blind controlled trial of milk products for prevention of gout flares. One hundred and twenty patients with recurrent gout flares were randomised to one of three arms: lactose powder control, SMP control and SMP enriched with GMP and G600 (SMP/GMP/G600). The primary end point was change in the frequency of gout flares using a daily flare diary measured monthly for 3 months.
The frequency of gout flares reduced in all three groups over the 3-month study period compared with baseline. Over the 3-month study period there was a significantly greater reduction in gout flares in the SMP/GMP/G600 group (analysis of covariance p(group)=0.031, Tukey post hoc test compared with lactose control, p=0.044). Following treatment with SMP/GMP/G600 over the 3-month period, greater improvements were also observed in pain and fractional excretion of uric acid, with trends to greater improvement in tender joint count. Similar adverse event rates and discontinuation rates were observed between the three groups.
This is the first reported controlled trial of dietary intervention in patients with gout, and suggests that SMP enriched with GMP and G600 may reduce the frequency of gout flares.
Annals of the rheumatic diseases 01/2012; 71(6):929-34. DOI:10.1136/annrheumdis-2011-200156 · 10.38 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Milk fat is a natural product containing essential nutrients as well as fatty acids and other food factors with reported anti-cancer potential. Here bovine milk fat was tested for its ability to inhibit the growth of breast and colon cancers and their metastasis to the lung and liver; either alone or in combination with the chemotherapeutic agent paclitaxel. A diet containing 5% typical anhydrous milk fat (representing ~70% of the total dietary fat component) fed to Balb/c mice delayed the appearance of subcutaneous 4T1 breast and CT26 colon cancer tumours and inhibited their metastasis to the lung and liver, when compared to the control diet containing soybean oil as the only fat component. It augmented the inhibitory effects of paclitaxel on tumour growth and metastasis, and reduced the microvessel density of tumours. It displayed no apparent organ toxicity, but instead was beneficial for well-being of tumour-bearing mice by maintaining gastrocnemius muscle and epididymal adipose tissue that were otherwise depleted by cachexia. The milk fat diet ameliorated gut damage caused by paclitaxel in non-tumour-bearing mice, as evidenced by retention of jejunal morphology, villi length and intestinal γ-glutamyl transpeptidase activity, and inhibition of crypt apoptosis. It prevented loss of red and white blood cells due to both cancer-mediated immunosuppression and the cytotoxic effects of chemotherapy. The present study warrants the use of milk fat as an adjuvant to inhibit tumour metastasis during cancer chemotherapy, and to spare patients from the debilitating side-effects of cytotoxic drugs.