Effect of Transform Burn on Weight Loss (Transform)

October 16, 2023 updated by: 4Life Research, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satiety Score
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4Life Research, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brigham Young University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Vollmer, PhD, 4LIFE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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