Effect of Transform Burn on Weight Loss (Transform)

Effect of a Thermogenic Composition on Healthy Adult Women and Men in a 12-week Weight Management Study

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Transform Burn

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Sandy, Utah, United States, 84070
      • 4Life Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transform Burn; 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.

Dietary supplement: Transform Burn; 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.; Other Names: Active Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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).	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: 4Life Research, LLC
• Collaborators: Brigham Young University
• Investigators: Principal Investigator: David Vollmer, PhD, 4LIFE

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): June 22, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: RSC-009-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No