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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • 6714-32 Beach Blvd.,

    Buena Park, California, 90621

Other trials in United States

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.

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.

  1. 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)
  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.

  1. First posted16 Feb 2006 (estimated)
  2. Study startJan 2005
  3. Study completionJan 2006

Resources

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
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

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.

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