Resting Metabolic RatePhase 215KMHINCT04782024
A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
A Phase 2 study testing 7-Keto 50mg and 7-Keto 25mg in people with Resting Metabolic Rate and Overweight Subjects, run by KGK Science Inc. at 2 sites in United States.
Trial summary
This study will investigate the effect of two different doses of 7-Keto compared to placebo on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one third will be given the higher 7-Keto dose and one third will be given the placebo. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate, Overweight Subjects
- What is being tested?
- 7-Keto 50mg and 7-Keto 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2015to 4 Nov 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
KGK USA
Foothill Ranch, California, 92610
KGK USA
Orlando, Florida, 32806
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Parallel Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
This study will investigate the effect of two different doses of 7-Keto compared to placebo on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one third will be given the higher 7-Keto dose and one third will be given the placebo.
- Conditions
- Resting Metabolic Rate, Overweight Subjects
- Being tested
- 7-Keto 50mg, 7-Keto 25mg, Placebo
- Keywords
- Resting Metabolic Rate, 7-Keto-DHEA, Efficacy, Overweight Adults, Obese Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Keto 50mgDietary supplement
7-Keto 25mgDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| 7-Keto 50mg | Experimental | Not described Receives: Dietary Supplement: 7-Keto 50mg |
| 7-Keto 25mg | Experimental | Not described Receives: Dietary Supplement: 7-Keto 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting metabolic rate
Measured: 1 week: from baseline to end of study
Secondary outcomes (2)
Change in total body water
Measured: 1 week: from baseline to end of study
Change in total body fat
Measured: 1 week: from baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start30 Sep 2015
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resting Metabolic RateStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InterHealth Nutraceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782024
- Sponsor's protocol ID
- 15KMHI
- Acronym
- 15KMHI
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Parallel Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
- ClinicalTrials.gov ID
- NCT04782024
- Acronym / sponsor ID
- 15KMHI / 15KMHI
- Conditions
- Resting Metabolic Rate, Overweight Subjects
- Keywords
- Resting Metabolic Rate, 7-Keto-DHEA, Efficacy, Overweight Adults, Obese Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- InterHealth Nutraceuticals, Inc.
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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.
This study will investigate the effect of two different doses of 7-Keto compared to placebo on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one third will be given the higher 7-Keto dose and one third will be given the placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| 7-Keto 50mg | Experimental | Dietary Supplement: 7-Keto 50mg |
| 7-Keto 25mg | Experimental | Dietary Supplement: 7-Keto 25mg |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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:
- 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)
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| 7-Keto 50mg | Dietary supplement | 7-Keto 50mg |
| 7-Keto 25mg | Dietary supplement | 7-Keto 25mg |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in resting metabolic rate
Time frame: 1 week: from baseline to end of study
2 secondary outcomes
Change in total body water
Time frame: 1 week: from baseline to end of study
Change in total body fat
Time frame: 1 week: from baseline to end of study
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 26 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7-Keto 50mg and 7-Keto 25mg in people with Resting Metabolic Rate and Overweight Subjects, run by KGK Science Inc. at 2 sites in United States.
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 19 inclusion and 18 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 resting metabolic rate (time frame: 1 week: from baseline to end of study). 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 26 Apr 2021.