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

• ClinicalTrials.gov Identifier: NCT02188251
• Recruitment Status: Completed
• First Posted: July 11, 2014
• Last Update Posted: August 13, 2015
• Sponsor: KGK Science Inc.
• Collaborator: Gencor Pacific Limited
• Information provided by (Responsible Party): KGK Science Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Body Weight	Dietary Supplement: Activamp; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• 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
• Study Start Date: September 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in body weight [ Time Frame: Baseline to week 12 ]

Secondary Outcome Measures :

1. Change in calculated BMI [ Time Frame: baseline to week 12 ]
2. Change in calculated percent body fat [ Time Frame: Baseline to week 12 ]
3. Change in calculated body fat mass [ Time Frame: Baseline to week 12 ]
4. Change in calculated lean body mass [ Time Frame: Baseline to week 12 ]
5. Change in total body fat percentage [ Time Frame: Baseline to week 12 ]
   As determined by DXA scan
6. Change in total fat mass [ Time Frame: Baseline to week 12 ]
   As determined by DXA scan
7. Change in total lean mass [ Time Frame: Baseline to week 12 ]
   As determined by DXA scan
8. Change in percent android fat [ Time Frame: Baseline to week 12 ]
   As determined by DXA scan
9. Change in percent gynoid fat [ Time Frame: Baseline to week 12 ]
   As determined by DXA scan
10. Change in percent trunk and legs fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
11. Change in percent abdominal fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
12. Change in anthropometric measurements [ Time Frame: Baseline to 12 weeks ]
    Waist and Hip circumference
13. Change in blood AMPK activity [ Time Frame: Baseline to week 12 ]
14. Change in blood metabolic parameters [ Time Frame: Baseline to 12 weeks ]
    lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol
15. Change in blood safety parameters [ Time Frame: Baseline to week 12 ]
    CBC, electrolytes, markers of kidney and liver function
16. Changes in safety vital signs [ Time Frame: Baseline to week 12 ]
    Blood pressure, heart rate
17. Incidence of adverse events [ Time Frame: Baseline to week 12 ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

KGK Science Inc.

Gencor Pacific Limited

Investigators

• Principal Investigator: Dale Wilson, MD; KGK Science Inc.

More Information

• Responsible Party: KGK Science Inc.
• ClinicalTrials.gov Identifier: NCT02188251
• Other Study ID Numbers: 14AWHG
• First Posted: July 11, 2014
• Last Update Posted: August 13, 2015
• Last Verified: August 2015

Keywords provided by KGK Science Inc.:

Activamp; Gynostemma pentaphyllum; Body weight; Fat Loss; Metabolic markers; Overweight participants; DXA; AMPK

Additional relevant MeSH terms:

Body Weight; Overweight