Effects of Ancient Grains-based Diet in a Closed Community
Condition: Gluten Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease or wheat allergy. This clinical condition has been named
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat
      causes the symptoms in NCGS patients, and the investigators also showed that these patients
      had a high frequency of coexistent multiple food hypersensitivity. It is also believed that
      this condition is worldwide increasing, due to the evolution of wheat breeding (i.e.
      consumption of wheats with high gluten content), and that "ancient" wheat flour varieties are
      better tolerated by NCWS patients than the "modern" ones. This effect could be related to a
      lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study
      is to evaluate the effect of a diet based on ancient grains in a "closed" community (i.e.
      nuns from enclosed religious order) as regard to 1) main haematochemical parameters and
      vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from
      peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with
      ancient grains.
    

Detailed description: 
      Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease or wheat allergy. This clinical condition has been named
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat
      causes the symptoms in NCGS patients, and the investigators also showed that these patients
      had a high frequency of coexistent multiple food hypersensitivity. Therefore, NCWS
      pathogenesis has been attributed to very different mechanisms: innate or adaptive immunity,
      non IgE-mediated food allergy, amylase/trypsine inhibitors pro-inflammatory effects,
      incomplete digestion and/or absorption of fermentable oligosaccharides and disaccharides,
      monosaccharides and polyols, and, finally, psychological effect. The clinical picture of NCWS
      is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
      and anemia). It is also believed that this condition is worldwide increasing, due to the
      evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that
      "ancient" wheat flour varieties are better tolerated by NCWS patients than the "modern" ones.
      More in details, it has been demonstrated that in patients with NCWS foods containing modern
      (i.e. "Manitoba") wheat flour varieties may trigger immunological mechanisms of inflammation
      (i.e. CXCL10 secretion) and may alter intestinal permeability; on the contrary, these effects
      was not observed with wheat flour from ancient (i.e. "Kamut" or "Senatore Cappelli")
      varieties. Therefore, the aim of the study is to evaluate the effect of a diet based on
      ancient grains (i.e. a mixture of "Tumminia", "Perciasacchi", "Senatore-Cappelli" and
      "Margherito" grains) in a "closed" community (i.e. nuns from enclosed religious order) as
      regard to: 1) main haematochemical parameters and vitamins (serum creatinine, serum
      glutamic-oxaloacetic transaminase, serum glutamic-pyruvic transaminase, hemoglobin, serum
      iron, serum ferritin, blood glucose, serum sodium, total cholesterol, glycated hemoglobin,
      vitamin B12, and vitamin D), 2) intestinal microbiota (bacterial flora), and 3) cytokines
      production from peripheral blood mononuclear cells (PBMC), before and after the diet period
      (30 days) with ancient grains.
    

Intervention name(s): Ancient wheat flours
Intervention type(s): Other
Intervention description(s): Ancient wheat flours will be administered in open label for 30 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Modern grains; ancient grains; immunologic response; microbiota