NCT03336086

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2012

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2012

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

September 17, 2017

Last Update Submit

November 7, 2017

Conditions

LymphocytesWeight LossViral DiseasesImmunityAnti-obesity Agents

Outcome Measures

Primary Outcomes (1)

  • lymphocyte subgroups

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

    6 months

Secondary Outcomes (9)

  • Body Mass Index

    6 months

  • Biomarkers

    6 months

  • Systolic blood pressure

    6 months

  • diastolic blood pressure

    6 months

  • Weight

    6 months

  • +4 more secondary outcomes

Study Arms (2)

experimental

OTHER

This group underwent a weight loss program

Combination Product: weight loss program

control

NO INTERVENTION

This group underwent adlibitum diet + physical activity

Interventions

weight loss programCOMBINATION_PRODUCT

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

Also known as: experimental
experimental

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • any disease
  • any medication use
  • iron and zinc deficiency
  • any supplement use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight LossVirus Diseases

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 17, 2017

First Posted

November 8, 2017

Study Start

March 20, 2012

Primary Completion

November 30, 2012

Study Completion

December 25, 2012

Last Updated

November 8, 2017

Record last verified: 2017-10