Back to resultsEffect of Transform Burn on Weight Loss (Transform)
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transform Burn
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria: Individuals could participate who were at least 18 years old and not smokers. Not currently taking a dietary supplement or prescription for weight loss. Exercising volunteers were asked to maintain their regimen consistently throughout the course of the 12-week study and caffeine drinking volunteers maintained their caffeine intake consistently throughout the course of the 12-week study. Exclusion Criteria: Participants were not allowed to participate if they were pregnant or planning to become pregnant in the following 12 weeks, or lactating. Individuals were not allowed to participate if they were taking any stimulant medications.
Sites / Locations
- 4Life Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transform Burn
Arm Description
Participants were supplied with one bottle of study product (Transform Burn) for each visit, labeled with their participant number. They were required to take the product consisting of 4 capsules per day, taken on an empty stomach at least 30 minutes prior to eating each morning, 5 days on Monday through Friday. Product was taken at the beginning of each visit, except for Week 0 visit for a total of 12 weeks and bottles were returned at each visit.
Outcomes
Primary Outcome Measures
Satiety Score
Results obtained from a validated ten-point scale Visual Analog Scale (VAS). On a scale 1 - 10, with the lowest being 1 and the highest being 10.
Resting Metabolic Rate
Resting metabolic rate (RMR) was measured by MedGem by MicroLife Medical Home Solutions, participants were in quiet, thermo-neutral environment, in a seated position, resting in a comfortable or reclined position for 5-15 minutes prior to measurement, without caffeine, food or exercise for at least four hours, with mouth-piece and nose-clip on, making sure of a good seal around the mouth and nose, holding MedGem device with arm support (e. g., pillow or opposite hand).
Blood Pressures
Both systolic and diastolic pressures were measured using the Omron Intellisense digital blood pressure monitor, Model HEM-739. Participants were measured in a seated position, left arm rested on the chair (or table) so that the cuff was at the same level as the heart, returned the palm upward, remained still and not talk.
Heart Rates
Heart rates were measured using the Omron Intellisense digital blood pressure monitor, Model HEM-739. Participants were measured in a seated position, left arm rested on the chair (or table) so that the cuff was at the same level as the heart, returned the palm upward, remained still and not talk.
Glucose Levels
Glucose levels were measured by CardioChek Plus. Participants were measured in a seated position with the index finger cleaned with an alcohol wipe dry until dried, a sterile lancet was used to puncture the skin on the side of the fingertip, around 100 microliter of blood was collected. With the glucose test strip already inserted into the device, 35-40 microliter of blood was applied to the test strip window and results appeared in approximately two minutes after.
Cholesterol Levels
Cholesterol levels were measured by CardioChek Plus. Participants were measured in a seated position with the index finger cleaned with an alcohol wipe dry until dried, a sterile lancet was used to puncture the skin on the side of the fingertip, around 100 microliter of blood was collected.
Body Fat
Body fat were measured by a pre-calibrated Tanita BC-418 Body Composition Analyzer, participants were measured in a standing position with shoes and socks removed, without exercise for at least four hours prior to the measurement, on an empty bladder, with both arms held straight down, not touching sides, inner thighs not touching, and feet cleaned.
Body Weight
Body weights were measured by a pre-calibrated Tanita BC-418 Body Composition Analyzer, participants were measured in a standing position with shoes and socks removed, without exercise for at least four hours prior to the measurement, on an empty bladder, with both arms held straight down, not touching sides, inner thighs not touching, and feet cleaned.
Waist and Hip Ratio (WHR)
Waist and hip circumference measurements were measured according to the US National Health and Nutrition Examination Survey III protocol. Participants were measured in a standing position, waist measurement was made at the high point of the iliac crest, hip measurement was made at the maximum extension of the buttocks, tape was parallel to the floor and snug, but not compressing skin.
Secondary Outcome Measures
Full Information
NCT ID
NCT06092840
First Posted
October 11, 2023
Last Updated
October 16, 2023
Sponsor
4Life Research, LLC
Collaborators
Brigham Young University
1. Study Identification
Unique Protocol Identification Number
NCT06092840
Brief Title
Effect of Transform Burn on Weight Loss
Acronym
Transform
Official Title
Effect of a Thermogenic Composition on Healthy Adult Women and Men in a 12-week Weight Management Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4Life Research, LLC
Collaborators
Brigham Young University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract to support body composition, weight management, and improve parameters related to energy, hunger, and satiety on healthy adult women and men over a 12-week interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transform Burn
Arm Type
Experimental
Arm Description
Participants were supplied with one bottle of study product (Transform Burn) for each visit, labeled with their participant number. They were required to take the product consisting of 4 capsules per day, taken on an empty stomach at least 30 minutes prior to eating each morning, 5 days on Monday through Friday. Product was taken at the beginning of each visit, except for Week 0 visit for a total of 12 weeks and bottles were returned at each visit.
Intervention Type
Dietary Supplement
Intervention Name(s)
Transform Burn
Other Intervention Name(s)
Active Treatment
Intervention Description
Study product Transform Burn contains dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract.
Primary Outcome Measure Information:
Title
Satiety Score
Description
Results obtained from a validated ten-point scale Visual Analog Scale (VAS). On a scale 1 - 10, with the lowest being 1 and the highest being 10.
Time Frame
12 weeks
Title
Resting Metabolic Rate
Description
Resting metabolic rate (RMR) was measured by MedGem by MicroLife Medical Home Solutions, participants were in quiet, thermo-neutral environment, in a seated position, resting in a comfortable or reclined position for 5-15 minutes prior to measurement, without caffeine, food or exercise for at least four hours, with mouth-piece and nose-clip on, making sure of a good seal around the mouth and nose, holding MedGem device with arm support (e. g., pillow or opposite hand).
Time Frame
12 weeks
Title
Blood Pressures
Description
Both systolic and diastolic pressures were measured using the Omron Intellisense digital blood pressure monitor, Model HEM-739. Participants were measured in a seated position, left arm rested on the chair (or table) so that the cuff was at the same level as the heart, returned the palm upward, remained still and not talk.
Time Frame
12 weeks
Title
Heart Rates
Description
Heart rates were measured using the Omron Intellisense digital blood pressure monitor, Model HEM-739. Participants were measured in a seated position, left arm rested on the chair (or table) so that the cuff was at the same level as the heart, returned the palm upward, remained still and not talk.
Time Frame
12 weeks
Title
Glucose Levels
Description
Glucose levels were measured by CardioChek Plus. Participants were measured in a seated position with the index finger cleaned with an alcohol wipe dry until dried, a sterile lancet was used to puncture the skin on the side of the fingertip, around 100 microliter of blood was collected. With the glucose test strip already inserted into the device, 35-40 microliter of blood was applied to the test strip window and results appeared in approximately two minutes after.
Time Frame
12 weeks
Title
Cholesterol Levels
Description
Cholesterol levels were measured by CardioChek Plus. Participants were measured in a seated position with the index finger cleaned with an alcohol wipe dry until dried, a sterile lancet was used to puncture the skin on the side of the fingertip, around 100 microliter of blood was collected.
Time Frame
12 weeks
Title
Body Fat
Description
Body fat were measured by a pre-calibrated Tanita BC-418 Body Composition Analyzer, participants were measured in a standing position with shoes and socks removed, without exercise for at least four hours prior to the measurement, on an empty bladder, with both arms held straight down, not touching sides, inner thighs not touching, and feet cleaned.
Time Frame
12 weeks
Title
Body Weight
Description
Body weights were measured by a pre-calibrated Tanita BC-418 Body Composition Analyzer, participants were measured in a standing position with shoes and socks removed, without exercise for at least four hours prior to the measurement, on an empty bladder, with both arms held straight down, not touching sides, inner thighs not touching, and feet cleaned.
Time Frame
12 weeks
Title
Waist and Hip Ratio (WHR)
Description
Waist and hip circumference measurements were measured according to the US National Health and Nutrition Examination Survey III protocol. Participants were measured in a standing position, waist measurement was made at the high point of the iliac crest, hip measurement was made at the maximum extension of the buttocks, tape was parallel to the floor and snug, but not compressing skin.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals could participate who were at least 18 years old and not smokers.
Not currently taking a dietary supplement or prescription for weight loss.
Exercising volunteers were asked to maintain their regimen consistently throughout the course of the 12-week study and caffeine drinking volunteers maintained their caffeine intake consistently throughout the course of the 12-week study.
Exclusion Criteria:
Participants were not allowed to participate if they were pregnant or planning to become pregnant in the following 12 weeks, or lactating.
Individuals were not allowed to participate if they were taking any stimulant medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vollmer, PhD
Organizational Affiliation
4LIFE
Official's Role
Principal Investigator
Facility Information:
Facility Name
4Life Research
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Transform Burn on Weight Loss
We'll reach out to this number within 24 hrs