Effect of Transform Burn on Weight Loss

Sponsor
4Life Research, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT06092840
Collaborator
Brigham Young University (Other)
36
1
1
5.3
6.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Transform Burn
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of a Thermogenic Composition on Healthy Adult Women and Men in a 12-week Weight Management Study
Actual Study Start Date :
Mar 23, 2016
Actual Primary Completion Date :
Jun 22, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Satiety Score [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.

    2. Resting Metabolic Rate [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).

    3. Blood Pressures [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.

    4. Heart Rates [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.

    5. Glucose Levels [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.

    6. Cholesterol Levels [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.

    7. Body Fat [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.

    8. Body Weight [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.

    9. Waist and Hip Ratio (WHR) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 4Life Research Sandy Utah United States 84070

    Sponsors and Collaborators

    • 4Life Research, LLC
    • Brigham Young University

    Investigators

    • Principal Investigator: David Vollmer, PhD, 4LIFE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    4Life Research, LLC
    ClinicalTrials.gov Identifier:
    NCT06092840
    Other Study ID Numbers:
    • RSC-009-01
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 23, 2023