Effects of Ancient Grains-based Diet in a Closed Community

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Ancient Grains-based Diet in a Closed Community

Conditions
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Gluten Sensitivity

Intervention / Treatment
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* Other: Ancient wheat flours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nuns from the Congregazione delle Suore Collegine della Santa Famiglia, Palermo, Italy. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ancient wheat flours<br>We prospectively will survey 30 nuns from the Congregazione delle Suore Collegine della Santa Famiglia, Palermo, Italy. The subjects will be recruited between January 2017 and June 2017 and will be examined before and after the diet period (30 days) with ancient grains, undergoing clinical evaluation and blood and feces samples collection. Ancient wheat flours will be administered in open label for 30 days | Other: Ancient wheat flours<br>* Ancient wheat flours will be administered in open label for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory Values evaluation | Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet. | Change from baseline at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiota (bacterial flora) by feces samples examination | Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet. | Change from baseline at 30 days | 
| Cytokines production from PBMC | Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains. | Cytokines production from PBMC after the diet period (30 days) with ancient grains | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Modern grains, ancient grains, immunologic response, microbiota