An interventional study of Black tea and Placebo in Focus of Study: 1- Effect of Tea Consumption on Gut Microbiota and Focus of Study: 2- Effect of Tea Consumption on Body-iron Status, sponsored by University of Reading. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by University of Reading · Not applicable, Interventional, and Screening
Iron is an essential micronutrient for nearly all living organisms, including microbes. The adult human body contains approximately 3-5 g of iron (45-55 mg/kg of body weight in adult women and men, respectively). Iron-deficiency related anaemia (IDA) is a major public health problem that affects more than 2 billion people globally and this represents 24.8% of the world's population. According to World Health Organisation (WHO), iron deficiency is the most common cause of anaemia worldwide, with infants, children and women at higher risk, making it a global public health problem. Much iron deficiency is a result of poor iron dietary absorption since iron is poorly absorbed (\~15%). Absorption inhibition factors (iron chelators) like phytate and tannins, found in tea and vegetables have been reported to act as potent iron uptake inhibitors. Despite its health benefits, tea-containing polyphenols (tannins) have been associated with reduction and disruption of iron absorption, acting as inhibitors of non-haem iron uptake, potentially resulting in poor iron status. However, most studies on the effect of tea on iron absorption are largely based on isotope-labelled single meal studies and animal studies. Iron is a requirement of many microorganisms, as such changes in iron availability can also have an impact on the gut microbiota. Long-term controlled human intervention studies to investigate the effect of tea on iron absorption and the effect on gut microbiota composition are scarce. In addition, the impact of dietary tannins on the gut microbiota is not understood. Thus, this proposed human intervention trial will investigate the combined effect of tea-tannins on iron status, inflammation and gut microbiota composition. This will be the first study to consider this combination of factors.
University of Reading is the lead sponsor of 146 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Volunteers meeting inclusion/exclusion criteria will be given an appropriate number of black tea samples twice a day with main meals for the 4 weeks of the treatment.
Dietary Supplement: Black tea
Volunteers meeting inclusion/exclusion criteria will be given an appropriate number of placebo tea samples twice a day with main meals for the 4 weeks of the treatment.
Dietary Supplement: Placebo
Black tea twice a day for 4 weeks
Placebo tea twice a day for 4 weeks
Composition and diversity of the faecal microbiota of the individuals consuming tea/placebo during the 4 weeks intervention
Changes in composition and diversity of faecal microbiota in response to black tea intervention assessed by next generation sequences NGS
Time frame: 4 weeks intervention
Levels of faecal and urine metabolites of the individuals consuming tea/placebo during the 4 weeks intervention
Changes of metabolic profile during the intervention will be estimated in faecal and urine samples using Nuclear Magnetic Resonance (NMR)
Time frame: 4 weeks intervention
Levels of ferritin (ng/mL) as body-iron status indicators of the individuals consuming tea/placebo during the 4 weeks intervention
Ferritin will be monitored through blood samples collected during study visits.
Time frame: 4 weeks intervention
Changes in the concentration (pg/mL) of inflammation markers in plasma of the individuals consuming tea/placebo using enzyme-linked immunosorbent assays (ELISAs)
gut inflammation will be assessed by measuring concentration (pg/mL) of gut inflammatory markers as plasma intestinal fatty acid-binding protein and cytokines from plasma (e.g. IL-10, IL-6, TNFα). Samples will be analysed using enzyme-linked immunosorbent assays (ELISAs)
Time frame: 4 weeks intervention
Changes in the concentration (mcg/g) of faecal calprotectin (gut inflammatory marker) during tea intervention using enzyme-linked immunosorbent assays (ELISAs)
Gut inflammation will be assessed measuring concentration (mcg/g) of calprotectin. Increase in the levels of Calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation.
Time frame: 4 weeks intervention
Assessment of stool consistency
The Bristol stool chart will be provided to volunteer to measure stool consistency, the chart rate the stool consistency from 1-7 (solid - liquid) based on the shape of stool.
Time frame: 4 weeks intervention
Assessment of gastrointestinal symptoms
Daily assessment of gastrointestinal symptoms (abdominal pain, bloating or flatulence) will be recorded daily using daily diary.
Time frame: 4 weeks intervention
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of Reading