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临床试验/CTRI/2020/11/029135
CTRI/2020/11/029135尚未招募不适用

Measuring beta-carotene bioavailability, bioconversion and vitamin A status in humans.

Department of Biotechnology Government of India India Alliance1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年11月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
6
试验地点
1
主要终点
Beta carotene bioconversion efficiency

研究概览

简要总结

**Introduction:**Vitamin A is an important micronutrient and populations at risk of Vitamin A deficiency (VAD) includes pregnant and lactating women and school children (1). VAD is usually assessed by serum retinol, a qualitative indicator which is the most common biochemical parameter but it is homeostatically controlled until liver reserves become exteremely low. Recent data from our country using these indicators suggests that although clinical deficiency has declined, marginal vitamin A status may still be prevalent and difficult to diagnose (2). In addition, the effect of sub clinical vitamin A deficiency on human health and the appropriate way to manage it is unknown. The dominant strategy used for the elimination and prevention of vitamin A deficiency has been the use of high dose vitamin A capsules through supplementation programmes. Since Vitamin A overdosing is potentially possible with pre-formed Vitamin A, it does not happen when carotene is ingested. A good source of carotene is green leafy vegetables (GLV), and therefore, using an increased intake of GLV is also a worthwhile method to increase Vitamin A status (stores) in the body. However, when subjects are fed with GLV, it is thought that the carotene is converted into Vitamin A in the body with an efficiency ratio of 12:1 or 8:1 (that is, 8 moles of carotene convert to 1 mole of retinol) (3-7). However, this is not known with accuracy, and the efficiency may vary with nutritional status and source of carotene. Therefore, it is important to measure the beta-carotene bioavailability, bioconversion and vitamin A status in humans accurately before the Vitamin A stores can be measured.

**Justification / need for the study:**Increasing the intake of carotenoids, primarily through beta -carotene, is considered to be a safe way of restoring the vitamin A reserves of an individual because high doses of preformed vitamin A have adverse health effects (3).Since the current vitamin A equivalency ratio for beta -carotene is varying and have large inter-individual variations in both absorption and conversion (4–8), there is a need for quantifying the bioconversion efficiency in targeted population before measuring the their Vitamin A stores.

References:

  1. Wolf, G. Multiple functions of vitamin A. Physiol. Rev 1984. 64: 873–938.
  2. World Health Organization (WHO). Global prevalence of vitamin A deficiency in populations at risk 1995-2005. WHO Global Database on Vitamin A Deficiency. Geneva: WHO; 2009.
  3. Tang , G. 2010 . Bioconversion of dietary provitamin A carotenoids to vitamin A in humans. Am. J. Clin. Nutr. 91 : 1468S – 1473S .
  4. Borel , P. , P. Grolier , N. Mekki , Y. Boirie , Y. Rochette , B. Le Roy , M. C. Alexandre-Gouabau , D. Lairon , and V. Azais-Braesco .1998 . Low and high responders to pharmacological doses of beta-carotene: proportion in the population, mechanisms involved and consequences on beta-carotene metabolism. J. Lipid Res. 39 :2250 – 2260 .
  5. Hickenbottom , S. J. , J. R. Follett , Y. M. Lin , S. R. Dueker , B. J. Burri ,T. R. Neidlinger , and A. J. Clifford . 2002 . Variability in conversion of beta-carotene to vitamin A in men as measured by using a double-tracer study design. Am. J. Clin. Nutr. 75 : 900 – 907 .
  6. Leung , W. C. , S. Hessel , C. Meplan , J. Flint , V. Oberhauser , F. Tourniaire , J. E. Hesketh , J. von Lintig , and G. Lietz . 2009 . Two common single nucleotide polymorphisms in the gene encoding beta-carotene 15,15 ′ -monoxygenase alter beta-carotene metabolism in female volunteers. FASEB J. 23 : 1041 – 1053 .
  7. Lietz , G. , A. Oxley , W. Leung , and J. Hesketh . 2012 . Single nucleotide polymorphisms upstream from the beta -carotene 15,15 ′ -monoxygenase gene influence provitamin A conversion efficiency in female volunteers. J. Nutr. 142 : 161S – 165S .
  8. Sabrina J Hickenbottom, Jennifer R Follett, Yumei Lin, Stephen R Dueker, Betty J Burri, Terry R Neidlinger, Andrew J Clifford, Variability in conversion of β-carotene to vitamin A in men as measured by using a double-tracer study design, The American Journal of Clinical Nutrition, Volume 75, Issue 5, May 2002, Pages 900–907, https://doi.org/10.1093/ajcn/75.5.900

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Six healthy male and females with no chronic and acute illness for the last 3 months and with normal blood biochemistry.

排除标准

  • Those who are pregnant, smoking, or with high blood pressure, diabetes and with BMI greater than 30 kg/m2 or with liver/kidney/gastrointestinal disease, lipid metabolic disorders, and consuming multivitamin (containing vitamins A, C, E) or beta -carotene supplements 3 months prior to the study start.

结局指标

主要结局

Beta carotene bioconversion efficiency

时间窗: One time measurement with biospecimen collection at day 0, 1, 2, 7 and 14

次要结局

  • vitamin A status(Baseline)

研究者

发起方
Department of Biotechnology Government of India India Alliance
申办方类型
Government funding agency

研究点 (1)

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