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Completed

NCT Number: NCT03395262

An Examination of a Weight Loss Formula on Health

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active with caffeine

Dietary Supplement

Novel formula with caffeine

Active without caffeine

Dietary Supplement

Novel formula without caffeine

Placebo

Dietary Supplement

Dextrose placebo

Primary outcomes

  1. Body Composition - Weight

    Time frame: Measured every 4 weeks for 12 weeks

    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).

  2. Body Composition - Fat Mass

    Time frame: Measured every 4 weeks for 12 weeks

    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).

  3. Body Composition - Body Fat Percent

    Time frame: Measured every 4 weeks for 12 weeks

    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).

Secondary outcomes

  1. Body Composition - Lean Tissue Mass

    Time frame: Measured every 4 weeks for 12 weeks

    Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  2. Body Composition - Bone Mass

    Time frame: Measured every 4 weeks for 12 weeks

    Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  3. Body Composition - Fat Free Mass

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in fat free mass (sum of lean tissue mass and bone mass expressed in 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).

  4. Body Composition - Total Body Water

    Time frame: Measured every 4 weeks for 12 weeks

    Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  5. Resting Energy Expenditure - Caloric Expenditure

    Time frame: Measured every 4 weeks for 12 weeks

    Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  6. Resting Energy Expenditure - Respiratory Exchange Ratio

    Time frame: Measured every 4 weeks for 12 weeks

    Change in resting respiratory exchange ratio (RER) as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  7. Anthropometric Measures - Waist Circumference

    Time frame: Measured every 4 weeks for 12 weeks

    Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  8. Anthropometric Measures - Hip Circumference

    Time frame: Measured every 4 weeks for 12 weeks

    Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  9. Anthropometric Measures - Waist to Hip Ratio

    Time frame: Measured every 4 weeks for 12 weeks

    Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  10. Anthropometric Measures - Body Mass Index

    Time frame: Measured every 4 weeks for 12 weeks

    Change in body mass index (kg of body mass / height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  11. Dietary Energy Intake - Total Caloric Intake

    Time frame: Measured every 4 weeks for 12 weeks

    Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  12. Dietary Energy Intake - Carbohydrate

    Time frame: Measured every 4 weeks for 12 weeks

    Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  13. Dietary Energy Intake - Fat

    Time frame: Measured every 4 weeks for 12 weeks

    Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  14. Dietary Energy Intake - Protein

    Time frame: Measured every 4 weeks for 12 weeks

    Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  15. Resting Hemodynamics - Heart Rate

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  16. Resting Hemodynamics - Systolic Blood Pressure

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  17. Resting Hemodynamics - Diastolic Blood Pressure

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  18. Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose

    Time frame: Measured every 4 weeks for 12 weeks

    Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  19. Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin

    Time frame: Measured every 4 weeks for 12 weeks

    Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  20. Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance

    Time frame: Measured every 4 weeks for 12 weeks

    Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  21. Blood Chemistry Markers of Health - Lipid Profile - Triglyderides

    Time frame: Measured every 4 weeks for 12 weeks

    Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  22. Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol

    Time frame: Measured every 4 weeks for 12 weeks

    Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  23. Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins

    Time frame: Measured every 4 weeks for 12 weeks

    Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  24. Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins

    Time frame: Measured every 4 weeks for 12 weeks

    Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  25. Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio

    Time frame: Measured every 4 weeks for 12 weeks

    Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  26. Blood Chemistry Markers of Health - Catabolic Markers - Creatinine

    Time frame: Measured every 4 weeks for 12 weeks

    Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  27. Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen

    Time frame: Measured every 4 weeks for 12 weeks

    Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  28. Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio

    Time frame: Measured every 4 weeks for 12 weeks

    Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  29. Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase

    Time frame: Measured every 4 weeks for 12 weeks

    Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  30. Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase

    Time frame: Measured every 4 weeks for 12 weeks

    Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  31. Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase

    Time frame: Measured every 4 weeks for 12 weeks

    Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  32. Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase

    Time frame: Measured every 4 weeks for 12 weeks

    Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  33. Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase

    Time frame: Measured every 4 weeks for 12 weeks

    Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  34. Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells

    Time frame: Measured every 4 weeks for 12 weeks

    Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  35. Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes

    Time frame: Measured every 4 weeks for 12 weeks

    Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  36. Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count

    Time frame: Measured every 4 weeks for 12 weeks

    Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  37. Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte

    Time frame: Measured every 4 weeks for 12 weeks

    Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  38. Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells

    Time frame: Measured every 4 weeks for 12 weeks

    Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  39. Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin

    Time frame: Measured every 4 weeks for 12 weeks

    Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  40. Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit

    Time frame: Measured every 4 weeks for 12 weeks

    Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  41. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume

    Time frame: Measured every 4 weeks for 12 weeks

    Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  42. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin

    Time frame: Measured every 4 weeks for 12 weeks

    Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  43. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration

    Time frame: Measured every 4 weeks for 12 weeks

    Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  44. Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width

    Time frame: Measured every 4 weeks for 12 weeks

    Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  45. Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count

    Time frame: Measured every 4 weeks for 12 weeks

    Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  46. Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume

    Time frame: Measured every 4 weeks for 12 weeks

    Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  47. Blood Chemistry Markers of Health - Appetite Hormone - Leptin

    Time frame: Measured every 4 weeks for 12 weeks

    Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  48. International Physical Activity Questionnaire (IPAQ) - Work Domain

    Time frame: Measured every 4 weeks for 12 weeks

    Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  49. International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain

    Time frame: Measured every 4 weeks for 12 weeks

    Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  50. International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain

    Time frame: Measured every 4 weeks for 12 weeks

    Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  51. International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain

    Time frame: Measured every 4 weeks for 12 weeks

    Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  52. International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score

    Time frame: Measured every 4 weeks for 12 weeks

    Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  53. Satiety Questionnaire - Perceptions of Appetite

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  54. Satiety Questionnaire - Perceptions of Hunger

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  55. Satiety Questionnaire - Perceptions of Satisfaction with Food

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  56. Satiety Questionnaire - Perceptions of Feelings of Fullness

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  57. Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  58. Sleep Quality Questionnaire - Sleep Duration

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  59. Sleep Quality Questionnaire - Sleep Quality

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  60. Sleep Quality Questionnaire - Enthusiasm

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  61. Sleep Quality Questionnaire - Sleep Disturbances

    Time frame: Measured every 4 weeks for 12 weeks

    Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  62. Perceptions of Side Effects - Dizziness

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of dizziness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  63. Perceptions of Side Effects - Headache

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of headache using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  64. Perceptions of Side Effects - Tachycardia

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of tachycardia using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  65. Perceptions of Side Effects - Palpitations

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of palpitations using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  66. Perceptions of Side Effects - Dyspnea

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of dyspnea using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  67. Perceptions of Side Effects - Nervousness

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of nervousness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  68. Perceptions of Side Effects - Blurred Vision

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of blurred vision using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

  69. Perceptions of Side Effects - Other Side Effects

    Time frame: Measured every 4 weeks for 12 weeks

    Change in perceptions of other side effects using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk

Acronym: NB14

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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