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Effects of Ancient Grains-based Diet in a Closed Community

Primary Purpose

Gluten Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ancient wheat flours
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gluten Sensitivity focused on measuring Modern grains, ancient grains, immunologic response, microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • Congregazione delle Suore Collegine della Santa Famiglia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ancient wheat flours

Arm Description

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

Outcomes

Primary Outcome Measures

Laboratory Values evaluation
Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.

Secondary Outcome Measures

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.
Cytokines production from PBMC
Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.

Full Information

First Posted
December 30, 2016
Last Updated
July 9, 2017
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT03020511
Brief Title
Effects of Ancient Grains-based Diet in a Closed Community
Official Title
Effects of Ancient Grains-based Diet in a Closed Community
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluten Sensitivity
Keywords
Modern grains, ancient grains, immunologic response, microbiota

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ancient wheat flours
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Ancient wheat flours
Intervention Description
Ancient wheat flours will be administered in open label for 30 days
Primary Outcome Measure Information:
Title
Laboratory Values evaluation
Description
Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.
Time Frame
Change from baseline at 30 days
Secondary Outcome Measure Information:
Title
Intestinal microbiota (bacterial flora) by feces samples examination
Description
Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet.
Time Frame
Change from baseline at 30 days
Title
Cytokines production from PBMC
Description
Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.
Time Frame
Cytokines production from PBMC after the diet period (30 days) with ancient grains

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nuns from the "Congregazione delle Suore Collegine della Santa Famiglia", Palermo, Italy. Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Carroccio, PhD
Organizational Affiliation
University of Palermo
Official's Role
Study Director
Facility Information:
Facility Name
Congregazione delle Suore Collegine della Santa Famiglia
City
Palermo
ZIP/Postal Code
90135
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22825366
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. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
Results Reference
result
PubMed Identifier
24533607
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.
Results Reference
result
PubMed Identifier
24275240
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. No abstract available.
Results Reference
result
PubMed Identifier
25625764
Citation
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. No abstract available.
Results Reference
result
PubMed Identifier
25430806
Citation
Carroccio A, Soresi M, D'Alcamo A, Sciume 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. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
Results Reference
result
PubMed Identifier
25694210
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.
Results Reference
result
PubMed Identifier
25624220
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. Food Chem. 2015 Jun 1;176:167-74. doi: 10.1016/j.foodchem.2014.12.061. Epub 2014 Dec 23.
Results Reference
result

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Effects of Ancient Grains-based Diet in a Closed Community

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