NCT02188251

Brief Summary

The purpose of this study is to determine the effects of Activamp, a product containing gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy overweight adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

July 10, 2014

Last Update Submit

August 11, 2015

Conditions

Body Weight

Keywords

ActivampGynostemma pentaphyllumBody weightFat LossMetabolic markersOverweight participantsDXAAMPK

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Baseline to week 12

Secondary Outcomes (17)

  • Change in calculated BMI

    baseline to week 12

  • Change in calculated percent body fat

    Baseline to week 12

  • Change in calculated body fat mass

    Baseline to week 12

  • Change in calculated lean body mass

    Baseline to week 12

  • Change in total body fat percentage

    Baseline to week 12

  • +12 more secondary outcomes

Study Arms (2)

Activamp

EXPERIMENTAL

Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks

Dietary Supplement: Activamp

Placebo

PLACEBO COMPARATOR

1 capsule taken twice daily for 12 weeks

Other: Placebo

Interventions

ActivampDIETARY_SUPPLEMENT
Activamp
PlaceboOTHER
Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female 21-55 years of age
  • BMI of 25.0 kg/m2 to 29.9 kg/m2 (± 1.0kg/m2)
  • Must have negative urine pregnancy test at screening
  • Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
  • Subject agrees to maintain their normal level of physical activity throughout the study
  • Weight has been stable for the last 3 months
  • Subject agrees to comply with study procedures
  • Healthy as determined by laboratory results, medical history and physical exam
  • Subject agrees not to participate in structured activity including resistance training and aerobic exercise more than 3 times per week
  • Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Subject who have experienced a greater than 10% variation in body weight in the past 3 months
  • History of, or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
  • History of surgery for weight loss (including gastric bypass or lapband)
  • History of conditions that could interfere with the test product or impede its absorption such as gastrointestinal disease (Crohn's disease) or experienced surgery (caecum or enterocele surgery)
  • Subjects diagnosed with Type II Diabetes
  • Subjects with active cancer (excluding basal cell carcinoma)
  • Subjects with active eating disorders
  • Subjects who have undergone anti-psychotic drug therapy within the past 2 months
  • Use of prescription or over the counter medications known to affect weight within 3 weeks of randomization or during the study
  • Use of any supplements, programs, or meal replacement products, other than those provided, intended to alter body weight within two weeks of screening or during the course of the study
  • Use of illicit drugs or history of drug or alcohol abuse within the past 6 months
  • Currently having more than 2 standard alcoholic drinks per day
  • Participation in a clinical research trial within 30 days prior to randomization
  • Allergy or sensitivity to test article ingredients
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dale Wilson, MD

    KGK Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 11, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

CA(1)