OverweightNCT03248804
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
A study testing Soy group and Non-soy group in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Weight Loss
- What is being tested?
- Soy group and Non-soy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2015to 29 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, Anschutz Health and Wellness Center
Aurora, Colorado, 80045
About this study
Official title: The Effect of Incorporating Soy Protein Foods in the Colorado Diet for 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.
Read the detailed description
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).
- Conditions
- Overweight, Obesity, Weight Loss
- Being tested
- Soy group, Non-soy group
- Keywords
- Obesity, Weight Loss, body composition, dietary protein
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy groupBehavioural
Non-soy groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Soy Group | Experimental | Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day. Receives: Behavioral: Soy group |
| Non-soy Group | Other | Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products. Receives: Behavioral: Non-soy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in % body weight at the end of a 16 week period
Measured: at month 4
Change from baseline in body fat at the end of 16 week period
Measured: at month 4
Change from baseline in % body weight at the end of a 52 week period
Measured: at month 12
Change from baseline in body fat at the end of a 52 week period
Measured: at month 12
Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
Measured: at month 4
Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
Measured: at month 12
Change from baseline in lipid panel results at end of 16 week period (LDL)
Measured: at month 4
Change from baseline in lipid panel results at end of 52 week period (LDLl)
Measured: at month 12
Change from baseline in lipid panel results at end of 16 week period (HDL)
Measured: at month 4
Change from baseline in lipid panel results at end of 52 week period (HDL)
Measured: at month 12
Change from baseline in lipid panel results at end of 16 week period (triglycerides)
Measured: at month 4
Change from baseline in lipid panel results at end of 52 week period (triglycerides)
Measured: at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start10 Mar 2015
- Primary completion29 Oct 2016
- Study completion29 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are assigned either to the soy group or the non-soy group.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Sponsor
- Investigators
- James O Hill, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248804
- Sponsor's protocol ID
- 14-1666
- Status last verified
- Nov 2018
- First submitted
- 9 Aug 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Banked blood samples may be shared with other researchers (with subject consent)
Publications
Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.
PubMed 15051857Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.
PubMed 15514267Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.
PubMed 7596371Anthony TG, McDaniel BJ, Knoll P, Bunpo P, Paul GL, McNurlan MA. Feeding meals containing soy or whey protein after exercise stimulates protein synthesis and translation initiation in the skeletal muscle of male rats. J Nutr. 2007 Feb;137(2):357-62. doi: 10.1093/jn/137.2.357.
PubMed 17237311Arciero PJ, Baur D, Connelly S, Ormsbee MJ. Timed-daily ingestion of whey protein and exercise training reduces visceral adipose tissue mass and improves insulin resistance: the PRISE study. J Appl Physiol (1985). 2014 Jul 1;117(1):1-10. doi: 10.1152/japplphysiol.00152.2014. Epub 2014 May 15.
PubMed 24833780Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr. 2011 Aug;141(8):1489-94. doi: 10.3945/jn.111.139840. Epub 2011 Jun 15.
PubMed 21677076Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.
PubMed 2228407Booth DA, Chase A, Campbell AT. Relative effectiveness of protein in the late stages of appetite suppression in man. Physiol Behav. 1970 Nov;5(11):1299-302. doi: 10.1016/0031-9384(70)90044-2. No abstract available.
PubMed 5524514Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
PubMed 16735482Brown EC, DiSilvestro RA, Babaknia A, Devor ST. Soy versus whey protein bars: effects on exercise training impact on lean body mass and antioxidant status. Nutr J. 2004 Dec 8;3:22. doi: 10.1186/1475-2891-3-22.
PubMed 15588291Elia D, Stadler K, Horvath V, Jakus J. Effect of soy- and whey protein-isolate supplemented diet on the redox parameters of trained mice. Eur J Nutr. 2006 Aug;45(5):259-66. doi: 10.1007/s00394-006-0593-z. Epub 2006 Mar 30.
PubMed 16575496Kalman D, Feldman S, Martinez M, Krieger DR, Tallon MJ. Effect of protein source and resistance training on body composition and sex hormones. J Int Soc Sports Nutr. 2007 Jul 23;4:4. doi: 10.1186/1550-2783-4-4.
PubMed 17908338Latner JD, Schwartz M. The effects of a high-carbohydrate, high-protein or balanced lunch upon later food intake and hunger ratings. Appetite. 1999 Aug;33(1):119-28. doi: 10.1006/appe.1999.0237.
PubMed 10447984Marmonier C, Chapelot D, Louis-Sylvestre J. Effects of macronutrient content and energy density of snacks consumed in a satiety state on the onset of the next meal. Appetite. 2000 Apr;34(2):161-8. doi: 10.1006/appe.1999.0302.
PubMed 10744905Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.
PubMed 18469287
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance.
- ClinicalTrials.gov ID
- NCT03248804
- Acronym / sponsor ID
- 14-1666
- Conditions
- Overweight, Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, body composition, dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 29 Oct 2016 (actual)
- Study completion
- 29 Oct 2016 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects are assigned either to the soy group or the non-soy group.
| Arm | Type | Receives |
|---|---|---|
| Soy Group | Experimental | Behavioral: Soy groupSubjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day. |
| Non-soy Group | Other | Behavioral: Non-soy groupSubjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy group | Behavioural | Soy Group |
| Non-soy group | Behavioural | Non-soy Group |
Primary outcome
Change from baseline in % body weight at the end of a 16 week period
Time frame: at month 4
Change from baseline in body fat at the end of 16 week period
Time frame: at month 4
Change from baseline in % body weight at the end of a 52 week period
Time frame: at month 12
Change from baseline in body fat at the end of a 52 week period
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (LDL)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (LDLl)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (HDL)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (HDL)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (triglycerides)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (triglycerides)
Time frame: at month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 15051857Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.
- Background: PubMed 15514267Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.
- Background: PubMed 7596371Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.
- Background: PubMed 17237311Anthony TG, McDaniel BJ, Knoll P, Bunpo P, Paul GL, McNurlan MA. Feeding meals containing soy or whey protein after exercise stimulates protein synthesis and translation initiation in the skeletal muscle of male rats. J Nutr. 2007 Feb;137(2):357-62. doi: 10.1093/jn/137.2.357.
- Background: PubMed 24833780Arciero PJ, Baur D, Connelly S, Ormsbee MJ. Timed-daily ingestion of whey protein and exercise training reduces visceral adipose tissue mass and improves insulin resistance: the PRISE study. J Appl Physiol (1985). 2014 Jul 1;117(1):1-10. doi: 10.1152/japplphysiol.00152.2014. Epub 2014 May 15.
- Background: PubMed 21677076Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr. 2011 Aug;141(8):1489-94. doi: 10.3945/jn.111.139840. Epub 2011 Jun 15.
- Background: PubMed 2228407Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.
- Background: PubMed 5524514Booth DA, Chase A, Campbell AT. Relative effectiveness of protein in the late stages of appetite suppression in man. Physiol Behav. 1970 Nov;5(11):1299-302. doi: 10.1016/0031-9384(70)90044-2. No abstract available.
- Background: PubMed 16735482Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
- Background: PubMed 15588291Brown EC, DiSilvestro RA, Babaknia A, Devor ST. Soy versus whey protein bars: effects on exercise training impact on lean body mass and antioxidant status. Nutr J. 2004 Dec 8;3:22. doi: 10.1186/1475-2891-3-22.
- Background: PubMed 16575496Elia D, Stadler K, Horvath V, Jakus J. Effect of soy- and whey protein-isolate supplemented diet on the redox parameters of trained mice. Eur J Nutr. 2006 Aug;45(5):259-66. doi: 10.1007/s00394-006-0593-z. Epub 2006 Mar 30.
- Background: PubMed 17908338Kalman D, Feldman S, Martinez M, Krieger DR, Tallon MJ. Effect of protein source and resistance training on body composition and sex hormones. J Int Soc Sports Nutr. 2007 Jul 23;4:4. doi: 10.1186/1550-2783-4-4.
- Individual participant dataSharing planned: Undecided. Banked blood samples may be shared with other researchers (with subject consent)
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James O Hill, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy group and Non-soy group in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in % body weight at the end of a 16 week period (time frame: at month 4). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248804, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.