A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants (14AWHG)

A Randomized, Double-blind, Placebo Controlled, Parallel Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants

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.

Study Overview

• Status: Completed
• Conditions: Body Weight
• Intervention / Treatment: Other: Placebo; Dietary supplement: Activamp

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Abnormal lab test results or any other medical or psychological condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activamp; Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks	Dietary supplement: Activamp
Placebo Comparator: Placebo; 1 capsule taken twice daily for 12 weeks	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		Baseline to week 12
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	As determined by DXA scan	Baseline to week 12
Change in total fat mass	As determined by DXA scan	Baseline to week 12
Change in total lean mass	As determined by DXA scan	Baseline to week 12
Change in percent android fat	As determined by DXA scan	Baseline to week 12
Change in percent gynoid fat	As determined by DXA scan	Baseline to week 12
Change in percent trunk and legs fat	As determined by DXA scan	Baseline to week 12
Change in percent abdominal fat	As determined by DXA scan	Baseline to week 12
Change in anthropometric measurements	Waist and Hip circumference	Baseline to 12 weeks
Change in blood AMPK activity		Baseline to week 12
Change in blood metabolic parameters	lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol	Baseline to 12 weeks
Change in blood safety parameters	CBC, electrolytes, markers of kidney and liver function	Baseline to week 12
Changes in safety vital signs	Blood pressure, heart rate	Baseline to week 12

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Gencor Pacific Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: DXA; Body weight; AMPK; Gynostemma pentaphyllum; Activamp; Fat Loss; Metabolic markers; Overweight participants
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: 14AWHG