Increase Intake of Vegetables or TomatoesVEG1NCT02287441
Feasibility Study to Increase Vegetable Consumption
A study testing Tomato and Raw in people with Increase Intake of Vegetables or Tomatoes and Health, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The objective of this study is to determine if differences exist in the total vegetable intake of groups that eat either tomato products versus raw vegetable product. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Increase Intake of Vegetables or Tomatoes, Health
- What is being tested?
- Tomato and Raw
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2014to 12 Apr 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking men and women ages 25-60 years of age with BMI between 18.5-29.9
- Generally healthy as determined by health history questionnaire
- Weight stable
- Consume a typical western diet
- Access to grocery store with Hunt's tomato products and raw vegetable availability
- Have general cooking skills and kitchen equipped for general food preparation
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- Primary shopper and food preparer in household
- Access to internet and ability to complete ASA24
- Past smokers will be allowed in the study if smoking cessation is >1 year (preferred > 2 years).
Who cannot join
- Smokers
- Current vegetable intake is atypical in type or amount relative to typical American diet
- Currently dieting or taking weight loss medication or weight loss supplements
- Change in weight of more than 5% in the past month
- Special or atypical diet - e.g., vegetarian/vegan, gluten free, excessively high or low energy
- Allergic to common food(s) (dairy, soy, nut/peanut, wheat, intolerance to tomatoes)
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- Have fasting blood glucose concentrations >125 mg/dL
- Had cancer other than non-melanoma skin cancer in previous 5 yrs
- Unwilling to eat vegetables
- History of eating disorder or clinical depression as assessed by validated questionnaires.
- Presence of chronic disease or condition (e.g. diabetes, irritable bowel syndrome)
- Chronic or acute gastrointestinal disorder
- Females who are pregnant or breastfeeding
- An athlete in training or highly active person whose dietary intake is greater than average
- Investigator is uncertain about subject's capability or willingness to comply with protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Feasibility Study Comparing Dietary Methods to Increase Vegetable Consumption
The objective of this study is to determine if differences exist in the total vegetable intake of groups that eat either tomato products versus raw vegetable product.
Read the detailed description
The proposed study is a crossover 2- arm pilot study comparing vegetable consumption of individuals partaking in two interventions: 1) Tomato Products (tomato) or 2) Vegetables Prepared Raw (raw).
A planned sample size of 20 will be recruited into the study. This study will require one initial screening visit and 5 weekly study visits. This study will take 4 weeks per subject to complete.
The trial will initiate with one screening visit which will last about 1-2 hours where the subjects' height, weight, BMI, waist circumference, fasting glucose, blood pressure and heart rate will be measured along with a survey related to general eating, health and exercise habits.
If willing and eligible to participate, a training of the online 24-hour recall software will be conducted during the screening visit. The subject will then use the software for an upcoming training week to recall foods for 3 days (2 weekdays and 1 weekend).
During the first study visit (End of Week 0) the subject will be randomly assigned an intervention sequence. The intervention sequence will dictate which intervention will be conducted for the first two weeks, leaving the second intervention for the last two weeks. Subjects will receive detailed explanation of their role and types of products they must buy during the upcoming week for the purpose of the study. They will be taught how to record on Vegetable Intake Diaries and be provided with vouchers and coupons to buy study products. They will also be given a recipe book for inspiration during the study to make appropriate meals.
The next study visits (End of Week 1-3) will take place by checking subjects' weight and then providing them with an Experience Questionnaire that is specific to their respective intervention assignment. The questionnaire will ask them to relate their study experiences over the past week. They will return any receipts and labels that were used to buy study products with the vouchers along with completed Vegetable Intake Diary. Before leaving, subjects will be provided with another set of Vegetable Intake Diaries and vouchers.
During Week 2 and 4, subjects will receive 3 surprise notifications (2 weekdays and 1 weekend) to complete the online food records. If they are unable to comply, a different day will be assigned.
The final study visit (End of Week 4) will initiate with anthropometric and vital measurements (height, weight, BMI, heart rate and blood pressure). Subject will complete Experience Questionnaire and return all receipts, labels, and diaries.
The randomization intervention sequence will be randomly assigned based on computer generated sequences. The primary difference between the intervention sequences is the order in which the subject will partake in the two intervention types. While in the tomato intervention, they will be asked to consume extra vegetable through tomato products. While in the raw intervention, however, they can only consume extra vegetables into their diet through raw vegetable products that have not been processed in any way.
Weekly Study Visits will be scheduled approximately 7 days apart.
- Conditions
- Increase Intake of Vegetables or Tomatoes, Health
- Being tested
- Tomato, Raw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomatoOther
Tomato Products (tomato)
RawOther
Vegetables Prepared Raw (raw).
| Study group | Role | What they receive |
|---|---|---|
| Raw Group | Placebo comparator | Vegetables Prepared Raw (raw) Receives: Other: Raw |
| Tomato Group | Experimental | Tomato Products (tomato) Receives: Other: Tomato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vegetable and nutrient consumption reported by subject through the 24-Hour online recall software.
Changes will be assessed based upon MyPlate.gov serving equivalents for vegetables.
Measured: 2 weeks
Secondary outcomes (1)
Overall experience with increasing vegetable intake through weekly Experience Questionnaires.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study start14 Nov 2014
- Primary completion22 May 2015
- Study completion12 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase Intake of Vegetables or TomatoesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287441
- Sponsor's protocol ID
- IRB2014-090
- Acronym
- VEG1
- Status last verified
- Jan 2021
- First submitted
- 6 Nov 2014
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Comparing Dietary Methods to Increase Vegetable Consumption
- ClinicalTrials.gov ID
- NCT02287441
- Acronym / sponsor ID
- VEG1 / IRB2014-090
- Conditions
- Increase Intake of Vegetables or Tomatoes, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2014 (actual)
- Primary completion
- 22 May 2015 (actual)
- Study completion
- 12 Apr 2016 (actual)
- First posted
- 10 Nov 2014 (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.
The objective of this study is to determine if differences exist in the total vegetable intake of groups that eat either tomato products versus raw vegetable product.
Detailed description
The proposed study is a crossover 2- arm pilot study comparing vegetable consumption of individuals partaking in two interventions: 1) Tomato Products (tomato) or 2) Vegetables Prepared Raw (raw).
A planned sample size of 20 will be recruited into the study. This study will require one initial screening visit and 5 weekly study visits. This study will take 4 weeks per subject to complete.
The trial will initiate with one screening visit which will last about 1-2 hours where the subjects' height, weight, BMI, waist circumference, fasting glucose, blood pressure and heart rate will be measured along with a survey related to general eating, health and exercise habits.
If willing and eligible to participate, a training of the online 24-hour recall software will be conducted during the screening visit. The subject will then use the software for an upcoming training week to recall foods for 3 days (2 weekdays and 1 weekend).
During the first study visit (End of Week 0) the subject will be randomly assigned an intervention sequence. The intervention sequence will dictate which intervention will be conducted for the first two weeks, leaving the second intervention for the last two weeks. Subjects will receive detailed explanation of their role and types of products they must buy during the upcoming week for the purpose of the study. They will be taught how to record on Vegetable Intake Diaries and be provided with vouchers and coupons to buy study products. They will also be given a recipe book for inspiration during the study to make appropriate meals.
The next study visits (End of Week 1-3) will take place by checking subjects' weight and then providing them with an Experience Questionnaire that is specific to their respective intervention assignment. The questionnaire will ask them to relate their study experiences over the past week. They will return any receipts and labels that were used to buy study products with the vouchers along with completed Vegetable Intake Diary. Before leaving, subjects will be provided with another set of Vegetable Intake Diaries and vouchers.
During Week 2 and 4, subjects will receive 3 surprise notifications (2 weekdays and 1 weekend) to complete the online food records. If they are unable to comply, a different day will be assigned.
The final study visit (End of Week 4) will initiate with anthropometric and vital measurements (height, weight, BMI, heart rate and blood pressure). Subject will complete Experience Questionnaire and return all receipts, labels, and diaries.
The randomization intervention sequence will be randomly assigned based on computer generated sequences. The primary difference between the intervention sequences is the order in which the subject will partake in the two intervention types. While in the tomato intervention, they will be asked to consume extra vegetable through tomato products. While in the raw intervention, however, they can only consume extra vegetables into their diet through raw vegetable products that have not been processed in any way.
Weekly Study Visits will be scheduled approximately 7 days apart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raw Group | Placebo comparator | Other: RawVegetables Prepared Raw (raw) |
| Tomato Group | Experimental | Other: TomatoTomato Products (tomato) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Non-smoking men and women ages 25-60 years of age with BMI between 18.5-29.9
- Generally healthy as determined by health history questionnaire
- Weight stable
- Consume a typical western diet
- Access to grocery store with Hunt's tomato products and raw vegetable availability
Key exclusion criteria (15 listed)
- Smokers
- Current vegetable intake is atypical in type or amount relative to typical American diet
- Currently dieting or taking weight loss medication or weight loss supplements
- Change in weight of more than 5% in the past month
- Special or atypical diet - e.g., vegetarian/vegan, gluten free, excessively high or low energy
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 |
|---|---|---|
| TomatoTomato Products (tomato) | Other | Tomato Group |
| RawVegetables Prepared Raw (raw). | Other | Raw Group |
Primary outcome
Changes in vegetable and nutrient consumption reported by subject through the 24-Hour online recall software.
Time frame: 2 weeks
Changes will be assessed based upon MyPlate.gov serving equivalents for vegetables.
1 secondary outcome
Overall experience with increasing vegetable intake through weekly Experience Questionnaires.
Time frame: 2 weeks
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 26 Jan 2021.
- Individual participant dataSharing planned: No
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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomato and Raw in people with Increase Intake of Vegetables or Tomatoes and Health, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 9 inclusion and 15 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 26 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Changes in vegetable and nutrient consumption reported by subject through the 24-Hour online recall software. (time frame: 2 weeks). 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 26 Jan 2021.