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

NCT04782024 | Completed Phase 2

• 1 other identifier: 15KMHI
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Resting Metabolic Rate; Overweight Subjects

Keywords

Resting Metabolic Rate; 7-Keto-DHEA; Efficacy; Overweight Adults; Obese Adults

Outcome Measures

Primary Outcomes (1)

• Change in resting metabolic rate

  1 week: from baseline to end of study

Secondary Outcomes (2)

• Change in total body water

  1 week: from baseline to end of study

• Change in total body fat

  1 week: from baseline to end of study

Other Outcomes (3)

• Number of incidents of abnormal lab results

  1 week: from baseline to end of study

• Number of incidents of adverse events

  1 week: from baseline to end of study

• Change in BMI

  1 week: from baseline to end of study

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

7-Keto 50mg

EXPERIMENTAL

Dietary Supplement: 7-Keto 50mg

7-Keto 25mg

EXPERIMENTAL

Dietary Supplement: 7-Keto 25mg

Interventions

7-Keto 50mg DIETARY_SUPPLEMENT

7-Keto 50mg

7-Keto 25mg DIETARY_SUPPLEMENT

7-Keto 25mg

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• InterHealth Nutraceuticals, Inc.: collaborator

Study Sites (2)

KGK USA

Foothill Ranch, California, 92610, United States

Location

KGK USA

Orlando, Florida, 32806, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: September 30, 2015
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

US (2)