NCT01423617

Brief Summary

The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects. This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

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

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

August 24, 2011

Results QC Date

March 25, 2015

Last Update Submit

April 5, 2015

Conditions

Overweight

Keywords

overweightweight lossbody fatwaist circumferencesatietyappetite

Outcome Measures

Primary Outcomes (2)

  • Change in Mean Body Weight (kg)

    Change in mean body weight at week 12 compared to baseline.

    12 weeks

  • Change in Mean Body Fat (kg)

    Change in mean body fat at week 12 compared to baseline

    12 weeks

Secondary Outcomes (11)

  • Number of Subjects Who Lost at Least 3% of Baseline Body Weight

    12 weeks

  • Changes in Waist Circumference (cm)

    12 weeks

  • Changes in Hip Circumference

    12 weeks

  • Changes in Waist-hip-ratio

    12 weeks

  • Changes in Body Fat Content (%)

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Zenoctil

ACTIVE COMPARATOR
Dietary Supplement: Zenoctil

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ZenoctilDIETARY_SUPPLEMENT

3 tablets 2 times daily

Zenoctil
PlaceboOTHER

3 tablets 2 times daily

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian males and females, age 18 to 60 years
  • kg/m2 ≤ BMI ≤32 kg/m2
  • Expressed desire for weight loss
  • Accustomed to 3 main meals a day
  • Consistent and stable body weight 3 months prior to study enrollment
  • Commitment to avoid the use of other weight loss products/programs during the study
  • Commitment to adhere to diet recommendation
  • Females' agreement to use appropriate birth control methods during the active study period
  • Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

You may not qualify if:

  • Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
  • History of diabetes mellitus or other endocrine disorders
  • Fasting blood glucose \>7 mmol/L
  • Treatment with systemic corticosteroids within the last 12 months
  • Current use of antidepressants
  • Uncontrolled hypertension (\>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
  • Presence of acute or history of chronic gastrointestinal disease
  • Schizophrenia or other diagnosed psychiatric disorders
  • Bariatric surgery
  • Abdominal surgery within the last 6 months
  • History of eating disorders like bulimia, anorexia nervosa
  • Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
  • Pregnancy or nursing
  • Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
  • More than 3 hours strenuous sport activity per week
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Grube

Berlin, Germany

Location

MeSH Terms

Conditions

OverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr Christof Jänicke
Organization
Analyze & Realize
cj@a-r.com
+49 30 40 00 83 23

Study Officials

  • Barbara Grube, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 23, 2015

Results First Posted

April 23, 2015

Record last verified: 2015-04

Locations

DE(1)