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NCT Number: NCT03248804

Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance

Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

About this study

This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows:

  • Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book.
  • Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females ages 18 - 55 years
  • BMI between 27-40
  • Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
  • Generally healthy
  • Able to exercise 70 minutes per day at moderate intensity
  • Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.

Exclusion criteria

  • Pregnant or trying to become pregnant.
  • Diagnosis of type 1 or type 2 diabetes
  • Individuals following a vegetarian only diet
  • Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
  • Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
  • Known renal disease
  • hypothyroidism
  • Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
  • Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
  • LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.

Treatment and study plan

Soy group

Behavioral

Non-soy group

Behavioral

Primary outcomes

  1. Change from baseline in % body weight at the end of a 16 week period

    Time frame: at month 4

  2. Change from baseline in body fat at the end of 16 week period

    Time frame: at month 4

  3. Change from baseline in % body weight at the end of a 52 week period

    Time frame: at month 12

  4. Change from baseline in body fat at the end of a 52 week period

    Time frame: at month 12

  5. Change from baseline in lipid panel results at end of 16 week period (total cholesterol)

    Time frame: at month 4

  6. Change from baseline in lipid panel results at end of 52 week period (total cholesterol)

    Time frame: at month 12

  7. Change from baseline in lipid panel results at end of 16 week period (LDL)

    Time frame: at month 4

  8. Change from baseline in lipid panel results at end of 52 week period (LDLl)

    Time frame: at month 12

  9. Change from baseline in lipid panel results at end of 16 week period (HDL)

    Time frame: at month 4

  10. Change from baseline in lipid panel results at end of 52 week period (HDL)

    Time frame: at month 12

  11. Change from baseline in lipid panel results at end of 16 week period (triglycerides)

    Time frame: at month 4

  12. Change from baseline in lipid panel results at end of 52 week period (triglycerides)

    Time frame: at month 12

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • DuPont Nutrition and Health

Registry information

Official study title

The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2017
Registry last updated
Nov 7, 2018

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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