Healthy PeopleNCT01075568
The Satiety Effect After Okara Compared to Porridge Eating
A study testing Nutrigal Okara - 100 in people with Healthy People, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To examine the satiety effect after eating of Okara. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Nutrigal Okara - 100
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Dec 2010
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age 20-65 years old
- Written Informed Consent
Who cannot join
- History of gastro-intestinal surgery
- On medication that may influence gastric emptying, or medication for weight loss
- Patient on PPI treatment, H2 Blockers or medication for weight loss
- Known allergies to soy
- Pregnancy or breast-feeding
- Smoking
Show all 10Show fewer
- Athletes
- Metabolic syndrome or diabetes mellitus
- Family history of metabolic syndrome or diabetes mellitus
- Weight loss > 2 kg during two months before the study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Medical Center
Tel Aviv
Nachum Vaisman, Prof', 00-972-3-6974807, vaisman@tasmc.health.gov.il
About this study
To examine the satiety effect after eating of Okara.
Read the detailed description
This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.
Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.
- Conditions
- Healthy People
- Being tested
- Nutrigal Okara - 100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrigal Okara - 100Dietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Nutrigal LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075568
- Sponsor's protocol ID
- TASMC-10-NV-016-CTIL
- Status last verified
- Feb 2010
- First submitted
- 17 Feb 2010
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Satiety Effect After Okara Compared to Porridge Eating
- ClinicalTrials.gov ID
- NCT01075568
- Acronym / sponsor ID
- TASMC-10-NV-016-CTIL
- Conditions
- Healthy People
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Nutrigal LTD
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Feb 2010 (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.
To examine the satiety effect after eating of Okara.
Detailed description
This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.
Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age 20-65 years old
- Written Informed Consent
Key exclusion criteria (10 listed)
- History of gastro-intestinal surgery
- On medication that may influence gastric emptying, or medication for weight loss
- Patient on PPI treatment, H2 Blockers or medication for weight loss
- Known allergies to soy
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Nutrigal Okara - 100 | Dietary supplement | – |
Primary outcome
To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrigal Okara - 100 in people with Healthy People, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Mar 2010. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof' (009-972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.. 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 3 Mar 2010.