NCT02703025

Brief Summary

Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

September 30, 2015

Last Update Submit

February 19, 2017

Conditions

Weight Loss

Keywords

Obesity, green coffee bean extract, weight management

Outcome Measures

Primary Outcomes (1)

  • weight loss

    12 weeks

Study Arms (1)

GCB 70 administered group

EXPERIMENTAL

Green coffee bean extract capsule 500mg, BD

Dietary Supplement: GCB-70

Interventions

GCB-70DIETARY_SUPPLEMENT

green coffee bean extract

GCB 70 administered group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agrees to written as well as audio-visual informed consent
  • Patients of either sex.
  • BMI \>25 kg/m2
  • Aged 18-65 years
  • Euthyroid
  • Not receiving any steroids

You may not qualify if:

  • i. Uncooperative Subjects ii. Lactating and Pregnant or planning to conceive females. iii. Physically/ mentally unwell as certified by physician-in-charge. iv. Participation in any other clinical trial with in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiology, King George's Medical University, Lucknow, UP, India

Lucknow, Uttar Pradesh, 226003, India

Location

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Dr Narsingh Verma, MD

    Dept of Physiology,King George's Medical University, Lucknow, UP, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: open level
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

March 9, 2016

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 23, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)