Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores
Condition: Iron-deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Rationale:

      According to the WHO, iron deficiency is still the most common and widespread nutritional
      disorder in the world. Current iron supplements have limitations in terms of bioavailability
      and tolerability. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively
      enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production
      of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in
      colonic pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and
      they have been proposed to potentially improve iron absorption as well.

      The primary objective of this study is to investigate the effect of an addition of GOS to an
      iron supplement on iron absorption in iron deplete, healthy, normal weight women.
    

Detailed description: 
      Iron deficiency is still the most common and widespread nutritional disorder in the world
      according to WHO. It does not only affect large numbers of women and children in the
      developing world, but also in industrialized countries. The current estimation is that 2
      billion people, or around 30% of the world's population, are anemic, of which around 50% is
      caused by iron deficiency. In industrialized countries, ID remains a public health concern in
      young women, affecting 16% of females between the ages of 12-49y in the United states.

      Iron supplementation has been recommended by the WHO as an approach to improve iron status in
      varying age and risk groups. Iron supplementation can be practical for high-risk groups such
      as pregnant women and has been proven effective for increasing hemoglobin levels in women.
      However, iron absorption from supplements is generally low and epigastric side effects reduce
      compliance. With the high global burden of iron deficiency and anemia, improved products
      which allow better absorption and reduce side effects are urgently needed.

      Targeted iron supplementation in high risk groups is the preferred way to treat iron
      deficiency. However, the recommendation is to consume iron supplements away from food in
      order to increase bioavailability which often causes nausea and epigastric pain and thus
      reduces compliance. Taken together with food, bioavailability of most supplements is reduced
      by about two thirds. Thus, a lot of unabsorbed iron passes into the colon where it can
      increase the abundance of enteropathogens.

      Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of
      beneficial colonic bacteria. GOS are enzymatically produced from lactose and are a mixture of
      glucose- and galactose- based di- and oligosaccharides of varying structure and seem to have
      an increased selectivity towards Bifidobacterium spp compared to other prebiotics. Prebiotics
      in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease
      luminal pH, which may reduce growth of enteropathogens. Through the reduction in colonic pH,
      prebiotics can enhance absorption of minerals such as calcium and magnesium and they have
      been proposed to potentially improve iron absorption, by reducing ferric to ferrous iron in
      the colon. Even though colonic absorption is minimal compared to absorption in the duodenum
      in healthy humans, it may become more important in iron deficiency or anemia as demonstrated
      in animal studies.

      The primary objective of this study is to investigate the effect of an addition of GOS to an
      iron supplement on iron absorption in iron deplete, healthy, normal weight women.
    

Intervention name(s): labeled ferrous fumarate; labeled ferrous fumarate + prebiotics; labeled ferrous sulfate + prebiotics
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): labeled iron as Ferrous Fumarate; labeled iron as Ferrous Fumarate + galacto-oligosaccharides; labeled iron as Ferrous Sulfate + galacto-oligosaccharides
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prebiotics; Galacto-oligosaccharides; Iron-deficiency