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

Body Weight Clinical Trial

— 14AWHG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188251
• Other study ID #: 14AWHG
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2014
• Last updated: August 11, 2015
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Body Weight
• Overweight

Intervention

Dietary Supplement:
• Activamp

Other:
• Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Gencor Pacific Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline to week 12	No
Secondary	Change in calculated BMI		baseline to week 12	No
Secondary	Change in calculated percent body fat		Baseline to week 12	No
Secondary	Change in calculated body fat mass		Baseline to week 12	No
Secondary	Change in calculated lean body mass		Baseline to week 12	No
Secondary	Change in total body fat percentage	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in total fat mass	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in total lean mass	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in percent android fat	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in percent gynoid fat	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in percent trunk and legs fat	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in percent abdominal fat	As determined by DXA scan	Baseline to week 12	No
Secondary	Change in anthropometric measurements	Waist and Hip circumference	Baseline to 12 weeks	No
Secondary	Change in blood AMPK activity		Baseline to week 12	No
Secondary	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	No
Secondary	Change in blood safety parameters	CBC, electrolytes, markers of kidney and liver function	Baseline to week 12	Yes
Secondary	Changes in safety vital signs	Blood pressure, heart rate	Baseline to week 12	Yes
Secondary	Incidence of adverse events		Baseline to week 12	Yes