OverweightNCT02380963
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
A study testing Colorado Diet with soy protein foods. and Colorado Diet with monetary payments in people with Overweight and Obesity, run by DuPont Nutrition and Health 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?
- Colorado Diet with soy protein foods. and Colorado Diet with monetary payments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 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
- 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, or peanut)
- Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC 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.
- Known renal disease
Show all 10Show fewer
- Clinical 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
Anschutz Health and Wellness Center, University of Colorado
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 comparing 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 State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health \& wellness questionnaires, and fitness measures will also be assessed throughout the study.
- Conditions
- Overweight, Obesity, Weight Loss
- Being tested
- Colorado Diet with soy protein foods., Colorado Diet with monetary payments
- Keywords
- Soy, Obesity, Weight Loss, Muscle, Cardiovascular Disease, Colorado Diet
- Medical subject headings
- Overweight, Obesity, Weight Loss, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorado Diet with soy protein foods.Dietary supplement
Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day.
Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day.
Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day.
Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars)
Colorado Diet with monetary paymentsBehavioural
Phase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day.
Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day.
Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day.
Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend.
| Study group | Role | What they receive |
|---|---|---|
| Colorado Diet with soy protein | Experimental | Not described Receives: Dietary Supplement: Colorado Diet with soy protein foods. |
| Colorado Diet | Active comparator | Not described Receives: Behavioral: Colorado Diet with monetary payments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight & body composition
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
Measured: 0, 2, 4, 8, 12 mths
Secondary outcomes (4)
Blood lipid and lipoproteins
Changes in lipids and lipoproteins will be measured using the Vertical Auto Profile (VAP) Test
Measured: 0, 2, 4, 8, 12 mths
C-reactive protein
Changes in inflammatory status will be assessed by measuring circulating c-reactive protein
Measured: 0, 2, 4, 8, 12 mths
Level of Fitness
Changes in the level of fitness will be measured by a 3 minute step test, grip strength, and flexibility testing.
Measured: 0, 12 mths
Quality of Life
Changes in the quality of life will be measured via Wellness Assessment Questionnaire
Measured: 0, 4, 8, 12 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- James O Hill, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380963
- Sponsor's protocol ID
- 1152341
- Status last verified
- Oct 2019
- First submitted
- 23 Feb 2015
- Last updated
- 4 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. 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
- NCT02380963
- Acronym / sponsor ID
- 1152341
- Conditions
- Overweight, Obesity, Weight Loss
- Keywords
- Soy, Obesity, Weight Loss, Muscle, Cardiovascular Disease, Colorado Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver
- Study start
- Feb 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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 comparing 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 State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health \& wellness questionnaires, and fitness measures will also be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorado Diet with soy protein | Experimental | Dietary Supplement: Colorado Diet with soy protein foods. |
| Colorado Diet | Active comparator | Behavioral: Colorado Diet with monetary payments |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
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, or peanut)
- Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC 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.
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 |
|---|---|---|
| Colorado Diet with soy protein foods.Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day. Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day. Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars) | Dietary supplement | Colorado Diet with soy protein |
| Colorado Diet with monetary paymentsPhase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day. Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day. Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day. Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend. | Behavioural | Colorado Diet |
Primary outcome
Body weight & body composition
Time frame: 0, 2, 4, 8, 12 mths
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
4 secondary outcomes
Blood lipid and lipoproteins
Time frame: 0, 2, 4, 8, 12 mths
C-reactive protein
Time frame: 0, 2, 4, 8, 12 mths
Level of Fitness
Time frame: 0, 12 mths
Quality of Life
Time frame: 0, 4, 8, 12 mths
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 4 Oct 2019.
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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 Colorado Diet with soy protein foods. and Colorado Diet with monetary payments in people with Overweight and Obesity, run by DuPont Nutrition and Health 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 5 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 4 Oct 2019. 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?
Body weight & body composition (time frame: 0, 2, 4, 8, 12 mths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2019.