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Completed

NCT Number: NCT06249698

Active Nutrition Program on Weight Loss

The study will evaluate the impact of the Active Nutrition 60-day program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin).

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, 38152, United States

About this study

To date, no controlled study exists to evaluate the impact of the Active Nutrition program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin). Therefore, the purpose of the proposed study is to evaluate the Active Nutrition weight loss program on body weight and related variables in a sample of overweight and obese men and women. Subjects in the Active Nutrition group will be compared to a control group of men and women following their standard diet, for a period of 60 days.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • body mass index 28-39.9 kilograms per square meter
  • weigh less than 500 lbs
  • able to fast overnight (greater than 10 hours)

Exclusion criteria

  • tobacco user
  • diagnosed with type 1 or 2 diabetes
  • diagnosed with liver disease
  • adversity to fiber or protein supplements
  • allergic to any of the ingredients
  • taking a weight loss dietary supplement or adhering to a weight loss plan for the month prior to or during the study
  • consumption of alcohol within 24 hours of study visit
  • consumption of caffeine within 24 hours of study visit
  • strenuous exercise within 24 hours of study visit
  • self-reported active infection or illness
  • pregnant or lactating

Treatment and study plan

meal replacements and supplements

Dietary Supplement

Consumed daily: 2 Nutrimeal Active meal replacement shake, 1 electrolyte replacement drink, 3 metabolism + supplements, 1 whole food meal, and whole food snacks consisting of fruits and vegetables. 1200-1600 calories per day

Primary outcomes

  1. Lipids

    Time frame: 0 days of assigned diet (baseline)

    Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in milligram per deciliter (mg/dL).

  2. Lipids

    Time frame: 30 days of assigned diet

    Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.

  3. Lipids

    Time frame: 60 days of assigned diet

    Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.

  4. Glucose

    Time frame: 0 days of assigned diet (baseline)

    Glucose will be measured in whole blood using a glucometer in mg/dL.

  5. Glucose

    Time frame: 30 days of assigned diet

    Glucose will be measured in whole blood using a glucometer in mg/dL.

  6. Glucose

    Time frame: 60 days of assigned diet

    Glucose will be measured in whole blood using a glucometer in mg/dL.

  7. Insulin

    Time frame: 0 days of assigned diet (baseline)

    Insulin will be measured from serum in micro-international units per milliliter.

  8. Insulin

    Time frame: 30 days of assigned diet

    Insulin will be measured from serum in micro-international units per milliliter.

  9. Insulin

    Time frame: 60 days of assigned diet

    Insulin will be measured from serum in micro-international units per milliliter.

  10. Body Weight

    Time frame: 0 days of assigned diet (baseline)

    Body weight will determined in kilograms using a digital scale.

  11. Body Weight

    Time frame: 30 days of assigned diet

    Body weight will determined in kilograms using a digital scale.

  12. Body Weight

    Time frame: 60 days of assigned diet

    Body weight will determined in kilograms using a digital scale.

  13. Waist circumference

    Time frame: 0 days of assigned diet (baseline)

    Waist circumference will be measured in centimeter.

  14. Waist circumference

    Time frame: 30 days of assigned diet

    Waist circumference will be measured in centimeter.

  15. Waist circumference

    Time frame: 60 days of assigned diet

    Waist circumference will be measured in centimeter.

  16. Hip circumference

    Time frame: 0 days of assigned diet (baseline)

    Hip circumference will be measured in centimeter.

  17. Hip circumference

    Time frame: 30 days of assigned diet

    Hip circumference will be measured in centimeter.

  18. Hip circumference

    Time frame: 60 days of assigned diet

    Hip circumference will be measured in centimeter.

  19. Body Mass Index

    Time frame: 0 days of assigned diet (baseline)

    body mass index will be calculated in kg per square meter from height and weight measurements.

  20. Body Mass Index

    Time frame: 30 days of assigned diet

    body mass index will be calculated in kg per square meter from height and weight measurements.

  21. Body Mass Index

    Time frame: 60 days of assigned diet

    body mass index will be calculated in kg per square meter from height and weight measurements.

  22. Body composition percentages

    Time frame: 0 days of assigned diet (baseline)

    body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.

  23. Body composition percentages

    Time frame: 30 days of assigned diet

    body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.

  24. Body composition percentages

    Time frame: 60 days of assigned diet

    body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.

  25. Body composition mass

    Time frame: 0 days of assigned diet (baseline)

    Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.

  26. Body composition mass

    Time frame: 30 days of assigned diet

    Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.

  27. Body composition mass

    Time frame: 60 days of assigned diet

    Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.

  28. Resting Heart Rate

    Time frame: 0 days of assigned diet (baseline)

    Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.

  29. Resting Heart Rate

    Time frame: 30 days of assigned diet

    Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.

  30. Resting Heart Rate

    Time frame: 60 days of assigned diet

    Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.

  31. Diastolic Blood Pressure

    Time frame: 0 days of assigned diet (baseline)

    Diastolic Blood Pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  32. Diastolic Blood Pressure

    Time frame: 30 days of assigned diet

    Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  33. Diastolic Blood Pressure

    Time frame: 60 days of assigned diet

    Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  34. Systolic Blood Pressure

    Time frame: 0 days of assigned diet (baseline)

    Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  35. Systolic Blood Pressure

    Time frame: 30 days of assigned diet

    Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  36. Systolic Blood Pressure

    Time frame: 60 days of assigned diet

    Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.

  37. Perceived wellness

    Time frame: 0 days of assigned diet (baseline)

    Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength

  38. Perceived wellness

    Time frame: 30 days of assigned diet

    Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength

  39. Perceived wellness

    Time frame: 60 days of assigned diet

    Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength

Other outcomes

  1. Digital images

    Time frame: 0 days of assigned diet (baseline)

    Digital images, for subjects consenting to photographing, will be collected from the subject's neck to knees from front, side, and back wearing form fitting clothing.

  2. Digital images

    Time frame: 30 days of assigned diet

    Digital images, for subjects consenting to photographing, will be collected from the subject's neck to knees from front, side, and back wearing form fitting clothing.

  3. Digital images

    Time frame: 60 days of assigned diet

    Digital images, for subjects consenting to photographing, will be collected from the subject's neck to knees from front, side, and back wearing form fitting clothing.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • USANA Health Sciences

Registry information

Official study title

Impact of Active Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

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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