Clinical trial NCT04782024: A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
Official title: A Randomized, Double-Blind, Placebo Controlled Parallel Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Resting Metabolic Rate
Overweight Subjects
Keywords: Resting Metabolic Rate
7-Keto-DHEA
Efficacy
Overweight Adults
Obese Adults
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: InterHealth Nutraceuticals, Inc.
First posted: 2021-03-04
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in resting metabolic rate
timeFrame: 1 week: from baseline to end of study
Secondary outcomes:
measure: Change in total body water
timeFrame: 1 week: from baseline to end of study
measure: Change in total body fat
timeFrame: 1 week: from baseline to end of study
Other outcomes:
measure: Number of incidents of abnormal lab results
timeFrame: 1 week: from baseline to end of study
measure: Number of incidents of adverse events
timeFrame: 1 week: from baseline to end of study
measure: Change in BMI
timeFrame: 1 week: from baseline to end of study
Locations:
city: Foothill Ranch
country: United States
facility: KGK USA
state: California
city: Orlando
country: United States
facility: KGK USA
state: Florida
Study officials:
References: