Body WeightPhase 214AWHGNCT02188251
A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
A Phase 2 study testing Activamp in people with Body Weight, run by KGK Science Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Activamp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Body Weight
- Being tested
- Activamp, Placebo
- Keywords
- Activamp, Gynostemma pentaphyllum, Body weight, Fat Loss, Metabolic markers, Overweight participants, DXA, AMPK
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivampDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Activamp | Experimental | Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks Receives: Dietary Supplement: Activamp |
| Placebo | Placebo comparator | 1 capsule taken twice daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline to week 12
Secondary outcomes (17)
Change in calculated BMI
Measured: baseline to week 12
Change in calculated percent body fat
Measured: Baseline to week 12
Change in calculated body fat mass
Measured: Baseline to week 12
Change in calculated lean body mass
Measured: Baseline to week 12
Change in total body fat percentage
As determined by DXA scan
Measured: Baseline to week 12
Change in total fat mass
As determined by DXA scan
Measured: Baseline to week 12
Change in total lean mass
As determined by DXA scan
Measured: Baseline to week 12
Change in percent android fat
As determined by DXA scan
Measured: Baseline to week 12
Change in percent gynoid fat
As determined by DXA scan
Measured: Baseline to week 12
Change in percent trunk and legs fat
As determined by DXA scan
Measured: Baseline to week 12
Change in percent abdominal fat
As determined by DXA scan
Measured: Baseline to week 12
Change in anthropometric measurements
Waist and Hip circumference
Measured: Baseline to 12 weeks
Change in blood AMPK activity
Measured: 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
Measured: Baseline to 12 weeks
Change in blood safety parameters
CBC, electrolytes, markers of kidney and liver function
Measured: Baseline to week 12
Changes in safety vital signs
Blood pressure, heart rate
Measured: Baseline to week 12
Incidence of adverse events
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188251
- Sponsor's protocol ID
- 14AWHG
- Acronym
- 14AWHG
- Status last verified
- Aug 2015
- First submitted
- 10 Jul 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02188251
- Acronym / sponsor ID
- 14AWHG / 14AWHG
- Conditions
- Body Weight
- Keywords
- Activamp, Gynostemma pentaphyllum, Body weight, Fat Loss, Metabolic markers, Overweight participants, DXA, AMPK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activamp | Experimental | Dietary Supplement: ActivampCapsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks |
| Placebo | Placebo comparator | Other: Placebo1 capsule taken twice daily for 12 weeks |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activamp | Dietary supplement | Activamp |
| Placebo | Other | Placebo |
Primary outcome
Change in body weight
Time frame: Baseline to week 12
17 secondary outcomes
Change in calculated BMI
Time frame: baseline to week 12
Change in calculated percent body fat
Time frame: Baseline to week 12
Change in calculated body fat mass
Time frame: Baseline to week 12
Change in calculated lean body mass
Time frame: Baseline to week 12
Change in total body fat percentage
Time frame: Baseline to week 12
Change in total fat mass
Time frame: Baseline to week 12
Change in total lean mass
Time frame: Baseline to week 12
Change in percent android fat
Time frame: Baseline to week 12
Change in percent gynoid fat
Time frame: Baseline to week 12
Change in percent trunk and legs fat
Time frame: Baseline to week 12
Change in percent abdominal fat
Time frame: Baseline to week 12
Change in anthropometric measurements
Time frame: Baseline to 12 weeks
Change in blood AMPK activity
Time frame: Baseline to week 12
Change in blood metabolic parameters
Time frame: Baseline to 12 weeks
Change in blood safety parameters
Time frame: Baseline to week 12
Changes in safety vital signs
Time frame: Baseline to week 12
Incidence of adverse events
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activamp in people with Body Weight, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.