An Examination of a Weight Loss Formula on Health

NCT ID: NCT03395262

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore 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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active with caffeine

Novel formula with caffeine

Group Type EXPERIMENTAL

Active with caffeine

Intervention Type DIETARY_SUPPLEMENT

Novel formula with caffeine

Active without caffeine

Novel formula without caffeine

Group Type ACTIVE_COMPARATOR

Active without caffeine

Intervention Type DIETARY_SUPPLEMENT

Novel formula without caffeine

Placebo

Dextrose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose placebo

Interventions

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Active with caffeine

Novel formula with caffeine

Intervention Type DIETARY_SUPPLEMENT

Active without caffeine

Novel formula without caffeine

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dextrose placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) between 25 and 34.9

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Richard B. Kreider

Executive Director, Human Clinical Research Facility

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB2016-0829FX

Identifier Type: -

Identifier Source: org_study_id

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