NCT03395262

Brief Summary

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 10, 2019

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

December 18, 2017

Last Update Submit

September 9, 2019

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (3)

  • Body Composition - Weight

    Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

    Measured every 4 weeks for 12 weeks

  • Body Composition - Fat Mass

    Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

    Measured every 4 weeks for 12 weeks

  • Body Composition - Body Fat Percent

    Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

    Measured every 4 weeks for 12 weeks

Secondary Outcomes (69)

  • Body Composition - Lean Tissue Mass

    Measured every 4 weeks for 12 weeks

  • Body Composition - Bone Mass

    Measured every 4 weeks for 12 weeks

  • Body Composition - Fat Free Mass

    Measured every 4 weeks for 12 weeks

  • Body Composition - Total Body Water

    Measured every 4 weeks for 12 weeks

  • Resting Energy Expenditure - Caloric Expenditure

    Measured every 4 weeks for 12 weeks

  • +64 more secondary outcomes

Study Arms (3)

Active with caffeine

EXPERIMENTAL

Novel formula with caffeine

Dietary Supplement: Active with caffeine

Active without caffeine

ACTIVE COMPARATOR

Novel formula without caffeine

Dietary Supplement: Active without caffeine

Placebo

PLACEBO COMPARATOR

Dextrose

Dietary Supplement: Placebo

Interventions

Active with caffeineDIETARY_SUPPLEMENT

Novel formula with caffeine

Active with caffeine
Active without caffeineDIETARY_SUPPLEMENT

Novel formula without caffeine

Active without caffeine
PlaceboDIETARY_SUPPLEMENT

Dextrose placebo

Placebo

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) between 25 and 34.9

You may not qualify if:

  • Recent history of weight change (+/- 10 lbs. within the past 3 months)
  • Uncontrolled metabolic disorders
  • Uncontrolled cardiovascular disorders
  • Currently taking prescription medications (birth control is allowed)
  • Currently taking dietary supplements for weight loss
  • Pregnant or plan to become pregnant
  • Have an intolerance to caffeine or other natural stimulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

ExerciseCaffeine

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Human Clinical Research Facility

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 10, 2018

Study Start

June 1, 2017

Primary Completion

March 31, 2018

Study Completion

December 31, 2018

Last Updated

September 10, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)