AllergyPhase 1/2NCT00292578
NAET® Testing Devices in Detection of Hypersensitivity to Cane Sugar
A Phase 1/2 study testing NAET Testing Modalities in people with Allergy and Fatigue, run by Nambudripad's Allergy Research Foundation at 1 site in United States.
Trial summary
Background: Studies have noted a correlation between food sensitivities and health disorders. Various commonly seen health problems may be caused by cane sugar since it is lavishly and frequently used by people worldwide. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Fatigue, Hypoglycemia
- What is being tested?
- NAET Testing Modalities
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Allergy to foods Undiagnosed health problems -
Who cannot join
- Cancer History of previous Anaphylaxis Any debilitating health problems
- -
Trial locations and contacts
1 site in 1 country.
About this study
Background: Studies have noted a correlation between food sensitivities and health disorders. Various commonly seen health problems may be caused by cane sugar since it is lavishly and frequently used by people worldwide.
Objective: This study evaluated the efficacy of NAET testing instruments in detecting hypersensitivities to cane sugar.
Materials and Methods: Seventy-four subjects volunteered for this study. They were asked to write down one of their major health problems, the amount of sugar consumed on a daily basis and any known health problem(s) related to sugar consumption. The following testing modalities were used in the study: (1). Allergy Symptom-Rating Scale (ASRS); (2). NST Rating Scale (NSTRS); (3). Pulse Difference Rating Scale (PDRS). Test-1 was done twice. Tests 2 and 3 were done three times each: once without contacting sugar and then contacting sugar at one minute and ten minutes.
Read the detailed description
NAET® testing devices are able to detect various levels of sensitivities to food substances in people (JNECM Vol. 1, No.1 \& 2, 2005) before they manifest in symptoms. Using NAET testing devices various levels of sensitivities to sugar can be easily detected and the people who are found to be sensitive to sugar can be advised to take strict preventive measures thus helping to alleviate their health problems.
Primary Objective of the Study The study will evaluate the efficacy of NAET® testing devices in detecting sensitivity to cane sugar (intolerance, hypersensitivity, or allergy) in a group of subjects from both sexes who had no prior knowledge of any health problems related to sugar consumption.
Sample Characteristics Eighty subjects from a group of medical professionals of both sexes who came to attend a medical conference volunteered to participate in the study. These volunteers came from different parts of Japan thus representing a large part of the country. Nine NAET® practitioners volunteered to supervise the entire study.
An on-site invitation to participate in the study was given to a group of 80 medical professionals who had come to attend a medical conference in Tokyo, Japan. The invitation to take part in the study was given to each member in the same morning at the time of registration for the conference. The 80 subjects who responded to the invitation were asked to complete an Allergy Symptom Rating Scale. They were asked to list an approximate amount of daily sugar consumption in number of teaspoons. They were also asked to record if they had suffered from any known sugar-related problems in the past. The five volunteer-subjects with known diabetes and hypoglycemia were excluded from the study.
All 75 subjects had completed the Allergy Symptom Rating Scale form (ASRS) initially prior to entering the study. After enrolling in the study, the examiners performed the Neuromuscular sensitivity testing (NST Rating Scale) on their subjects before touching the test sample and recording of the results. Initial radial pulse was taken and recorded.
(Detailed information on the Allergy Symptom-Rating scale (ASRS); NSTRS, and PDRS: Subject were asked to mark and rate their symptoms in their own words on a zero to ten scale where zero=normal; and ten=maximum discomfort): 0= no allergy; (1-3)=1=mild; (4-6)= 2=moderate; (7-10)=3=severe. After the initial testing (after completing ASRS form, NSTRS after balancing the body, and after initial pulse reading) each one of the subjects was given a test tube with clear liquid (dissolved sugar) in their hands. The examiners tested the NST of the subjects with them holding the sample-test tube in their hands and the results recorded. The radial pulse was also checked and recorded. Then they were asked to continue to hold the samples for full ten minutes. At the end of ten minutes, they were assigned to be tested for NST and Pulse by different examiners. While still holding the test tube in the hand, the radial pulse was tested and recorded; NST was perfomed and recorded and each one of them was asked to complete another Allergy Symptom Rating Scale.
After completing the initial test, the monitors moved the subjects one at a time to a different area and each one of them was asked to continue to hold the sample-tubes in their hands for the following ten minutes.
At the end of ten minutes' waiting period with the test tubes in their hands, each subject was given another ASRS form to record their symptoms one more time. They were also instructed to rate their symptoms on a zero to ten scale. Then the monitors ushered them to different examiners to check the NST and radial pulse one more time, while still holding the test tubes in their hands. The results were recorded in a separate paper and the monitors collected the results and sent for analysis.
- Conditions
- Allergy, Fatigue, Hypoglycemia, Hyperglycemia, Indigestion
- Being tested
- NAET Testing Modalities
- Keywords
- Allergy, Sugar Intolerance, Fatigue
- Medical subject headings
- Hypersensitivity, Fatigue, Hypoglycemia, Hyperglycemia, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAET Testing ModalitiesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will evaluate the efficacy of NAET® testing devices in detecting sensitivity to cane sugar (intolerance, hypersensitivity, or allergy) in a group of subjects from both sexes who had no prior knowledge of any health problems related to sugar
Secondary outcomes (1)
Improve opportunity to get better dietary management and guidance for a better life-style. This may reduce or prevent the risk of sugar-related problems at a later age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Nambudripad's Allergy Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Devi S Nambudripad, DC,L.Ac,PhD, Principal investigator, NAR Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292578
- Sponsor's protocol ID
- Hypersensitivity to Cane Sugar
- Other IDs
- narfoundation 112
- Status last verified
- Oct 2008
- First submitted
- 15 Feb 2006
- Last updated
- 17 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAET® Testing Devices in Detection of Hypersensitivity to Cane Sugar
- ClinicalTrials.gov ID
- NCT00292578
- Acronym / sponsor ID
- Hypersensitivity to Cane Sugar
- Conditions
- Allergy, Fatigue, Hypoglycemia, Hyperglycemia, Indigestion
- Keywords
- Allergy, Sugar Intolerance, Fatigue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Nambudripad's Allergy Research FoundationUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jan 2006
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Studies have noted a correlation between food sensitivities and health disorders. Various commonly seen health problems may be caused by cane sugar since it is lavishly and frequently used by people worldwide.
Objective: This study evaluated the efficacy of NAET testing instruments in detecting hypersensitivities to cane sugar.
Materials and Methods: Seventy-four subjects volunteered for this study. They were asked to write down one of their major health problems, the amount of sugar consumed on a daily basis and any known health problem(s) related to sugar consumption. The following testing modalities were used in the study: (1). Allergy Symptom-Rating Scale (ASRS); (2). NST Rating Scale (NSTRS); (3). Pulse Difference Rating Scale (PDRS). Test-1 was done twice. Tests 2 and 3 were done three times each: once without contacting sugar and then contacting sugar at one minute and ten minutes.
Detailed description
NAET® testing devices are able to detect various levels of sensitivities to food substances in people (JNECM Vol. 1, No.1 \& 2, 2005) before they manifest in symptoms. Using NAET testing devices various levels of sensitivities to sugar can be easily detected and the people who are found to be sensitive to sugar can be advised to take strict preventive measures thus helping to alleviate their health problems.
Primary Objective of the Study The study will evaluate the efficacy of NAET® testing devices in detecting sensitivity to cane sugar (intolerance, hypersensitivity, or allergy) in a group of subjects from both sexes who had no prior knowledge of any health problems related to sugar consumption.
Sample Characteristics Eighty subjects from a group of medical professionals of both sexes who came to attend a medical conference volunteered to participate in the study. These volunteers came from different parts of Japan thus representing a large part of the country. Nine NAET® practitioners volunteered to supervise the entire study.
An on-site invitation to participate in the study was given to a group of 80 medical professionals who had come to attend a medical conference in Tokyo, Japan. The invitation to take part in the study was given to each member in the same morning at the time of registration for the conference. The 80 subjects who responded to the invitation were asked to complete an Allergy Symptom Rating Scale. They were asked to list an approximate amount of daily sugar consumption in number of teaspoons. They were also asked to record if they had suffered from any known sugar-related problems in the past. The five volunteer-subjects with known diabetes and hypoglycemia were excluded from the study.
All 75 subjects had completed the Allergy Symptom Rating Scale form (ASRS) initially prior to entering the study. After enrolling in the study, the examiners performed the Neuromuscular sensitivity testing (NST Rating Scale) on their subjects before touching the test sample and recording of the results. Initial radial pulse was taken and recorded.
(Detailed information on the Allergy Symptom-Rating scale (ASRS); NSTRS, and PDRS: Subject were asked to mark and rate their symptoms in their own words on a zero to ten scale where zero=normal; and ten=maximum discomfort): 0= no allergy; (1-3)=1=mild; (4-6)= 2=moderate; (7-10)=3=severe. After the initial testing (after completing ASRS form, NSTRS after balancing the body, and after initial pulse reading) each one of the subjects was given a test tube with clear liquid (dissolved sugar) in their hands. The examiners tested the NST of the subjects with them holding the sample-test tube in their hands and the results recorded. The radial pulse was also checked and recorded. Then they were asked to continue to hold the samples for full ten minutes. At the end of ten minutes, they were assigned to be tested for NST and Pulse by different examiners. While still holding the test tube in the hand, the radial pulse was tested and recorded; NST was perfomed and recorded and each one of them was asked to complete another Allergy Symptom Rating Scale.
After completing the initial test, the monitors moved the subjects one at a time to a different area and each one of them was asked to continue to hold the sample-tubes in their hands for the following ten minutes.
At the end of ten minutes' waiting period with the test tubes in their hands, each subject was given another ASRS form to record their symptoms one more time. They were also instructed to rate their symptoms on a zero to ten scale. Then the monitors ushered them to different examiners to check the NST and radial pulse one more time, while still holding the test tubes in their hands. The results were recorded in a separate paper and the monitors collected the results and sent for analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Allergy to foods Undiagnosed health problems -
Key exclusion criteria (2 listed)
- Cancer History of previous Anaphylaxis Any debilitating health problems
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAET Testing Modalities | Procedure or surgery | – |
Primary outcome
The study will evaluate the efficacy of NAET® testing devices in detecting sensitivity to cane sugar (intolerance, hypersensitivity, or allergy) in a group of subjects from both sexes who had no prior knowledge of any health problems related to sugar
1 secondary outcome
Improve opportunity to get better dietary management and guidance for a better life-style. This may reduce or prevent the risk of sugar-related problems at a later age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- NAR Foundation is a nonprofit Research OrganizationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devi S Nambudripad, DC,L.Ac,PhD principal investigator
NAR Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NAET Testing Modalities in people with Allergy and Fatigue, run by Nambudripad's Allergy Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will evaluate the efficacy of NAET® testing devices in detecting sensitivity to cane sugar (intolerance, hypersensitivity, or allergy) in a group of subjects from both sexes who had no prior knowledge of any health problems related to sugar. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.