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Can the Reduction of Iron Availability Caused by Tea Consumption Change the Gut Microbiota Composition and Disrupt Host Body-iron Status

NCT05019573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Focus of Study: 1- Effect of Tea Consumption on Gut Microbiota
  • Focus of Study: 2- Effect of Tea Consumption on Body-iron Status

Interventions

DIETARY_SUPPLEMENT

Black tea

Black tea twice a day for 4 weeks

DIETARY_SUPPLEMENT

Placebo

Placebo tea twice a day for 4 weeks

Sponsors & Collaborators

  • Unilever R&D

    collaborator INDUSTRY

  • University of Reading

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2021-12-10
Completion
2022-01-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019573 on ClinicalTrials.gov