ClinicalTrials.gg
Sign In
CompletedNCT03336086Updated Nov 8, 2017

Effect of Weight Reduction on Immunity

A Phase 3 interventional study of weight loss program in Lymphocytes, Weight Loss and Viral Diseases, sponsored by Shiraz University of Medical Sciences. Completed. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-08.

Primary conditionVirus DiseasesRegistry: Weight LossReclassifiedWhy we changed it
Registry
Weight Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Virus Diseases
Why
  1. Weight Loss is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Virus Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shiraz University of Medical Sciences · Phase 3, Interventional, and Other

From the registry’s dates

  • Primary completion was Nov 2012, 13 years 11 months ago, and no results have been posted to the registry.
  • Registered 5 years 5 months after the study started (first participant enrolled Mar 2012, registered Sep 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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. 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

02

Conditions studied

  • Lymphocytes
  • Weight Loss
  • Viral Diseases
  • Immunity
  • Anti-obesity Agents

Browse trials for

03

In context

Virus Diseases Reclassified

656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.

This study's enrollment of 29 is below the median of 100 across 464 interventional studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.

Browse Shiraz University of Medical Sciences studies →

Compared within Virus Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >=30
  • female
  • healthy
  • no smoking
  • not lactating
  • not pregnant
  • no medication use

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • any disease
  • any medication use
  • iron and zinc deficiency
  • any supplement use
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Other
    experimental

    This group underwent a weight loss program

    Combination Product: weight loss program

  • No intervention
    control

    This group underwent adlibitum diet + physical activity

Interventions

  • Combination productweight loss program

    A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity

    Also known as: experimental

06

What researchers measure

Primary outcomes

  1. lymphocyte subgroups

    TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry

    Time frame: 6 months

Secondary outcomes

  1. Body Mass Index

    (Kg/m\^2) by equation

    Time frame: 6 months

  2. Biomarkers

    ZN, Iron (microgram/deciliter) by biochemical assessment

    Time frame: 6 months

  3. Systolic blood pressure

    (mmHg) by manometer

    Time frame: 6 months

  4. diastolic blood pressure

    (mmHg) by manometer

    Time frame: 6 months

  5. Weight

    (Kg) by Bioelectric impedance analyser

    Time frame: 6 months

  6. Fat Mass

    (Kg) by Bioelectric impedance analyser

    Time frame: 6 months

  7. Fat Free Mass

    (Kg) by Bioelectric impedance analyser

    Time frame: 6 months

  8. Trunk Fat

    (Kg) by Bioelectric impedance analyser

    Time frame: 6 months

  9. Waist circumference

    (cm) by meter tape

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2012 to primary completion in Nov 2012, 8 months.

Of 57 phase 3 interventional studies under Virus Diseases, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 24. This study's 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2017
First posted
Nov 8, 2017
StartActual
Mar 20, 2012
Primary completionActual
Nov 30, 2012
CompletionActual
Dec 25, 2012
Last update
Nov 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03336086
Lead sponsor
Shiraz University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences
Responsible party
Mahsa Mehrdad (Principal investigator, Shiraz University of Medical Sciences) — Principal investigator
First posted
Nov 8, 2017
Start date
Mar 20, 2012
Primary completion
Nov 30, 2012
Completion
Dec 25, 2012
Last update
Nov 8, 2017

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Virus Diseases →

Other studies from this sponsor

Shiraz University of Medical Sciences →

Start the discussion