CompletedPhase 2

A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults

United States138 participantsStarted 2015-09-30

Plain-language 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.

Who can participate

Age range

20 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in resting metabolic rate

Timeframe: 1 week: from baseline to end of study

Trial details

NCT IDNCT04782024

SponsorKGK Science Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-04

View on ClinicalTrials.gov More Resting Metabolic Rate trials

Who can participate

Age range

20 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).
. 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.

A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria