- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782024
A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults (15KMHI)
A Randomized, Double-Blind, Placebo Controlled Parallel Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Foothill Ranch, California, United States, 92610
- KGK USA
-
-
Florida
-
Orlando, Florida, United States, 32806
- KGK USA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female 20 to 55 years of age
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
- 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)
- BMI 25-34.9 ±1 kg/m2
- Stable weight defined as less than 5kg (approx. 11lbs) gained or lost in the past 3 months
- 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.
- Agreement to maintain current level of physical activity through the study and avoid exercising 24 hours prior to study visits
- Agreement to adopt a diet with a 500 kcal reduction for the duration of the study period.
- 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.
- Agreement to completely avoid consumption of energy drinks for 24 hours before the screening and baseline visits and for the duration of the study.
- 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
- Immunodeficiency (i.e. HIV positive, rheumatoid arthritis, history of organ transplant)
- Use of tobacco products and nicotine products.
- 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
- Unstable medical conditions
- Uncontrolled blood pressure (i.e. systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
- 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
- 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
- Abnormal ECG at screening
- 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)
- Currently taking anti-psychotic medication
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients
- Alcohol abuse (>2 standard alcoholic drinks per day)
- Current drug abuse or drug abuse within the past 6 months
- Use of marijuana for medical purposes
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: 7-Keto 50mg
|
|
Experimental: 7-Keto 25mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in resting metabolic rate
Time Frame: 1 week: from baseline to end of study
|
1 week: from baseline to end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in total body water
Time Frame: 1 week: from baseline to end of study
|
1 week: from baseline to end of study
|
Change in total body fat
Time Frame: 1 week: from baseline to end of study
|
1 week: from baseline to end of study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of incidents of abnormal lab results
Time Frame: 1 week: from baseline to end of study
|
Lab results from blood biochemistry and hematology (Na, K, Cl, creatinine, BUN, AST, ALT, GGT and bilirubin)
|
1 week: from baseline to end of study
|
Number of incidents of adverse events
Time Frame: 1 week: from baseline to end of study
|
1 week: from baseline to end of study
|
|
Change in BMI
Time Frame: 1 week: from baseline to end of study
|
1 week: from baseline to end of study
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15KMHI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resting Metabolic Rate
-
Pennington Biomedical Research CenterWeight Watchers InternationalCompletedResting Metabolic RateUnited States
-
MicrolifeCompletedResting Metabolic RateUnited States
-
Florida State UniversityCompletedHeart Rate Variability | Appetite | Resting Metabolic RateUnited States
-
Karolinska InstitutetThe Swedish Research Council; Swedish Heart Lung FoundationCompleted
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
-
AmgenWithdrawnHeart Transplantation, Elevated Resting Heart Rate
-
Iberoamerican Institute of Sports Science and Human...CompletedAthletic Injuries | Disability Physical | Resting Metabolic RateMexico
-
USDA Grand Forks Human Nutrition Research CenterCompleted
-
University of ThessalyCompletedBody Composition | Physical Fitness | Energy Expenditure | Resting Metabolic RateGreece
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States