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

KGK Science

Status and phase

Completed

Phase 2

Conditions

Body Weight

Treatments

Dietary Supplement: Activamp

Other: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02188251

14AWHG

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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