LymphocytesPhase 3NCT03336086
Effect of Weight Reduction on Immunity
A Phase 3 study testing weight loss program in people with Lymphocytes and Weight Loss, run by Shiraz University of Medical Sciences.
Trial summary
This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphocytes, Weight Loss, Viral Diseases
- What is being tested?
- weight loss program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2012to 25 Dec 2012
- Phase
- Phase 3
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >=30
- female
- healthy
- no smoking
- not lactating
- not pregnant
- no medication use
Who cannot join
- pregnancy
- any disease
- any medication use
- iron and zinc deficiency
- any supplement use
About this study
Official title: Reduction of Natural Killer Cell (CD16/56) and T-lymphocyte (CD3) Subset Counts After a Weight Loss Program Using Anti-obesity Drugs in Obese Women: a Non-randomized Controlled Trial
This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. At baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.
Read the detailed description
TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity
- Conditions
- Lymphocytes, Weight Loss, Viral Diseases, Immunity, Anti-obesity Agents
- Being tested
- weight loss program
- Medical subject headings
- Weight Loss, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss programCombination product
Also called experimental
A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
| Study group | Role | What they receive |
|---|---|---|
| experimental | Other | This group underwent a weight loss program Receives: Combination Product: weight loss program |
| control | No intervention | This group underwent adlibitum diet + physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte subgroups
TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry
Measured: 6 months
Secondary outcomes (9)
Body Mass Index
(Kg/m^2) by equation
Measured: 6 months
Biomarkers
ZN, Iron (microgram/deciliter) by biochemical assessment
Measured: 6 months
Systolic blood pressure
(mmHg) by manometer
Measured: 6 months
diastolic blood pressure
(mmHg) by manometer
Measured: 6 months
Weight
(Kg) by Bioelectric impedance analyser
Measured: 6 months
Fat Mass
(Kg) by Bioelectric impedance analyser
Measured: 6 months
Fat Free Mass
(Kg) by Bioelectric impedance analyser
Measured: 6 months
Trunk Fat
(Kg) by Bioelectric impedance analyser
Measured: 6 months
Waist circumference
(cm) by meter tape
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start20 Mar 2012
- Primary completion30 Nov 2012
- Study completion25 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphocytesStudies 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 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Responsible party
- Principal investigator, Mahsa Mehrdad, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336086
- Sponsor's protocol ID
- 900413
- Status last verified
- Oct 2017
- First submitted
- 17 Sep 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Natural Killer Cell (CD16/56) and T-lymphocyte (CD3) Subset Counts After a Weight Loss Program Using Anti-obesity Drugs in Obese Women: a Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03336086
- Acronym / sponsor ID
- 900413
- Conditions
- Lymphocytes, Weight Loss, Viral Diseases, Immunity, Anti-obesity Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Study start
- 20 Mar 2012 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 25 Dec 2012 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. At baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.
Detailed description
TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Other | Combination Product: weight loss programThis group underwent a weight loss program |
| control | No intervention | –This group underwent adlibitum diet + physical activity |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI >=30
- female
- healthy
- no smoking
- not lactating
Key exclusion criteria (5 listed)
- pregnancy
- any disease
- any medication use
- iron and zinc deficiency
- any supplement use
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 |
|---|---|---|
| weight loss programAlso: experimentalA low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity | Combination product | experimental |
Primary outcome
lymphocyte subgroups
Time frame: 6 months
TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry
9 secondary outcomes
Body Mass Index
Time frame: 6 months
Biomarkers
Time frame: 6 months
Systolic blood pressure
Time frame: 6 months
diastolic blood pressure
Time frame: 6 months
Weight
Time frame: 6 months
Fat Mass
Time frame: 6 months
Fat Free Mass
Time frame: 6 months
Trunk Fat
Time frame: 6 months
Waist circumference
Time frame: 6 months
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 8 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing weight loss program in people with Lymphocytes and Weight Loss, run by Shiraz University of Medical Sciences.
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 7 inclusion and 5 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
lymphocyte subgroups (time frame: 6 months). 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 8 Nov 2017.