Clinical trial NCT03395262: An Examination of a Weight Loss Formula on Health
Official title: An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Composition - Weight
timeFrame: Measured every 4 weeks for 12 weeks
measure: Body Composition - Fat Mass
timeFrame: Measured every 4 weeks for 12 weeks
measure: Body Composition - Body Fat Percent
timeFrame: Measured every 4 weeks for 12 weeks
Secondary outcomes:
measure: Body Composition - Lean Tissue Mass
timeFrame: Measured every 4 weeks for 12 weeks
measure: Body Composition - Bone Mass
timeFrame: Measured every 4 weeks for 12 weeks
measure: Body Composition - Fat Free Mass
timeFrame: Measured every 4 weeks for 12 weeks
measure: Body Composition - Total Body Water
timeFrame: Measured every 4 weeks for 12 weeks
measure: Resting Energy Expenditure - Caloric Expenditure
timeFrame: Measured every 4 weeks for 12 weeks
measure: Resting Energy Expenditure - Respiratory Exchange Ratio
timeFrame: Measured every 4 weeks for 12 weeks
measure: Anthropometric Measures - Waist Circumference
timeFrame: Measured every 4 weeks for 12 weeks
measure: Anthropometric Measures - Hip Circumference
timeFrame: Measured every 4 weeks for 12 weeks
measure: Anthropometric Measures - Waist to Hip Ratio
timeFrame: Measured every 4 weeks for 12 weeks
measure: Anthropometric Measures - Body Mass Index
timeFrame: Measured every 4 weeks for 12 weeks
measure: Dietary Energy Intake - Total Caloric Intake
timeFrame: Measured every 4 weeks for 12 weeks
measure: Dietary Energy Intake - Carbohydrate
timeFrame: Measured every 4 weeks for 12 weeks
measure: Dietary Energy Intake - Fat
timeFrame: Measured every 4 weeks for 12 weeks
measure: Dietary Energy Intake - Protein
timeFrame: Measured every 4 weeks for 12 weeks
measure: Resting Hemodynamics - Heart Rate
timeFrame: Measured every 4 weeks for 12 weeks
measure: Resting Hemodynamics - Systolic Blood Pressure
timeFrame: Measured every 4 weeks for 12 weeks
measure: Resting Hemodynamics - Diastolic Blood Pressure
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Lipid Profile - Triglyderides
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Creatinine
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume
timeFrame: Measured every 4 weeks for 12 weeks
measure: Blood Chemistry Markers of Health - Appetite Hormone - Leptin
timeFrame: Measured every 4 weeks for 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Work Domain
timeFrame: Measured every 4 weeks for 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain
timeFrame: Measured every 4 weeks for 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain
timeFrame: Measured every 4 weeks for 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain
timeFrame: Measured every 4 weeks for 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score
timeFrame: Measured every 4 weeks for 12 weeks
measure: Satiety Questionnaire - Perceptions of Appetite
timeFrame: Measured every 4 weeks for 12 weeks
measure: Satiety Questionnaire - Perceptions of Hunger
timeFrame: Measured every 4 weeks for 12 weeks
measure: Satiety Questionnaire - Perceptions of Satisfaction with Food
timeFrame: Measured every 4 weeks for 12 weeks
measure: Satiety Questionnaire - Perceptions of Feelings of Fullness
timeFrame: Measured every 4 weeks for 12 weeks
measure: Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction
timeFrame: Measured every 4 weeks for 12 weeks
measure: Sleep Quality Questionnaire - Sleep Duration
timeFrame: Measured every 4 weeks for 12 weeks
measure: Sleep Quality Questionnaire - Sleep Quality
timeFrame: Measured every 4 weeks for 12 weeks
measure: Sleep Quality Questionnaire - Enthusiasm
timeFrame: Measured every 4 weeks for 12 weeks
measure: Sleep Quality Questionnaire - Sleep Disturbances
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Dizziness
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Headache
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Tachycardia
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Palpitations
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Dyspnea
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Nervousness
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Blurred Vision
timeFrame: Measured every 4 weeks for 12 weeks
measure: Perceptions of Side Effects - Other Side Effects
timeFrame: Measured every 4 weeks for 12 weeks
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab - Human Clinical Research Facility
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: