An Examination of a Weight Loss Formula on Health (NB14)

Texas A&M University

Status: Completed

Conditions: Weight Loss

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Active without caffeine; Dietary Supplement: Active with caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03395262

IRB2016-0829FX

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

Active with caffeine

Experimental group

Description:

Novel formula with caffeine

Treatment:

Dietary Supplement: Active with caffeine

Active without caffeine

Active Comparator group

Description:

Novel formula without caffeine

Treatment:

Dietary Supplement: Active without caffeine

Placebo

Placebo Comparator group

Description:

Dextrose

Treatment:

Dietary Supplement: Placebo