| Eligibility |
Inclusion Criteria:
1. Male or female 20 to 55 years of age
2. If female, subject is not of child bearing potential. Defined as females who have had
a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal
(natural or surgically with > 1 year since last menstruation).
OR
Female subject of childbearing potential must agree to use a medically approved method
of non-hormonal birth control and have a negative urine pregnancy test result. Birth
Control methods must be initiated at least 14 days prior to randomization and must be
continued until 28 days after the end of study visit. Acceptable methods of birth
control include:
- Double barrier method
- Intrauterine devices (non-hormonal)
- Cervical caps or sponges
- Use of male/female condom
- Vasectomy of partner
- Non-heterosexual lifestyle
3. If female and currently experiencing menstrual cycles, subjects should have regular
menstrual cycles (28 ± 2 days) and must be in their follicular phase during the
duration of the study period (i.e. baseline to visit 3)
4. BMI 25-34.9 ±1 kg/m2
5. Stable weight defined as less than 5kg (approx. 11lbs) gained or lost in the past 3
months
6. Sedentary subjects; defined as subjects with a desk/inactive job, not engaging in any
regular sports or exercise programs either at an exercise facility or at home.
Occasional activity, low intensity yoga and walking at a regular pace are acceptable.
7. Agreement to maintain current level of physical activity through the study and avoid
exercising 24 hours prior to study visits
8. Agreement to adopt a diet with a 500 kcal reduction for the duration of the study
period.
9. Agreement to completely avoid caffeine consumption, such as coffee, tea and soft
drinks 24 hours before study visits and to limit consumption of coffee, tea and soft
drinks to 2 cups per day for all other days during the study.
10. Agreement to completely avoid consumption of energy drinks for 24 hours before the
screening and baseline visits and for the duration of the study.
11. Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant during the
course of the trial
2. Immunodeficiency (i.e. HIV positive, rheumatoid arthritis, history of organ
transplant)
3. Use of tobacco products and nicotine products.
4. Use of prescription, over-the-counter, or natural health products known to affect
weight and/or metabolic rate within 4 weeks of randomization and during the trial
5. Unstable medical conditions
6. Uncontrolled blood pressure (i.e. systolic blood pressure > 160 mmHg or diastolic
blood pressure > 100 mmHg)
7. Type I or II diabetes, metabolic disease or any condition that in the opinion of the
Qualified Investigator does not safely allow for a reduction in calorie intake
8. Any evidence of an eating disorder, such as anorexia or bulimia, or the presence of
any illness that might represent a potential cause of weight loss
9. Abnormal ECG at screening
10. Clinically significant abnormal laboratory results at screening (e.g. AST and/or ALT >
2 x ULN, and/or bilirubin > 2 x ULN; serum creatinine > 1.5 x ULN)
11. Currently taking anti-psychotic medication
12. Participation in a clinical research trial within 30 days prior to randomization
13. Allergy or sensitivity to study supplement ingredients
14. Alcohol abuse (>2 standard alcoholic drinks per day)
15. Current drug abuse or drug abuse within the past 6 months
16. Use of marijuana for medical purposes
17. Individuals who are cognitively impaired and/or who are unable to give informed
consent
18. Any other 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
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