Effects of Ancient Grains-based Diet in a Closed Community

Gluten Sensitivity Clinical Trial

Official title:

Effects of Ancient Grains-based Diet in a Closed Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020511
• Other study ID #: ACPM19
• Status: Completed
• Phase: N/A
• First received: December 30, 2016
• Last updated: July 9, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Nuns from the "Congregazione delle Suore Collegine della Santa Famiglia", Palermo, Italy.

Exclusion Criteria:

Related Conditions & MeSH terms

• Gluten Sensitivity

Intervention

Other:
• Ancient wheat flours
Ancient wheat flours will be administered in open label for 30 days

Locations

Country	Name	City	State
Italy	Congregazione delle Suore Collegine della Santa Famiglia	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. — View Citation

Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. A — View Citation

Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. — View Citation

Carroccio A, Soresi M, D'Alcamo A, Sciumè C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. — View Citation

Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996. Review. — View Citation

Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18. Review. — View Citation

Valerii MC, Ricci C, Spisni E, Di Silvestro R, De Fazio L, Cavazza E, Lanzini A, Campieri M, Dalpiaz A, Pavan B, Volta U, Dinelli G. Responses of peripheral blood mononucleated cells from non-celiac gluten sensitive patients to various cereal sources. Foo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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