Overcoming Resistance to Eating Cruciferous VegetablesNCT02012283
Influence of Spices on Mixed Vegetable Intake Including Brassica Vegetables
A study testing Food consumption in people with Overcoming Resistance to Eating Cruciferous Vegetables, run by University of California, Los Angeles.
Trial summary
This study is being done to determine that carefully designed spice mixtures can override any taste aversion to brassica vegetables, increase consumption of vegetable dishes which include brassica vegetables. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overcoming Resistance to Eating Cruciferous Vegetables
- What is being tested?
- Food consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30-60 years of age at screen.
- BMI >25 and <30
- In good health
- Eat <3 serving of vegetable per day.
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
- -
Who cannot join
- Any history of gastrointestinal disease except for appendectomy
- Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject allergic to spice or vegetables
- Any subject who currently uses tobacco products.
- Any subject who participates in vigorous physical activity on a regular basis.
- Any subject who is unable or unwilling to comply with the study protocol.
- -
About this study
Official title: Influence of Spices on Mixed Vegetable Intake Including Brassica
This study is being done to determine that carefully designed spice mixtures can override any taste aversion to brassica vegetables, increase consumption of vegetable dishes which include brassica vegetables.
Read the detailed description
This study is to determine the liking of vegetables, intentions to consume vegetables and differences in responses in consumption of three individual vegetables including: broccoli florets, cauliflower florets, baby spinach with and without spices added by measuring: (1) the actual intake of blanched dishes of vegetables using a modified Universal Eating Monitor when dishes are eaten plain or with added spices in random order; and (2) level of eating by baseline eating restraint using the Three Factor Eating Questionnaire (TFEQ).
This study will be conducted in healthy overweight subjects (30-60 years, Body Mass Index >25 and <30). A total of 20 subjects will be recruited (10 men and 10 women). Subjects will be further stratified by whether their level of restrained eating (10 high and 10 low restraint in each group). All participants will complete a general recruitment questionnaire which incorporates the TFEQ (Stunkard \& Messick, 1985, Cappelleri 2009) along with measures of food and drink preferences and allergies. To ensure large differences in restraint between groups, subjects will be pre-selected depending on their score on the TFEQ cognitive restraint scale, with scores greater than two defined as high restraint (HR), and two or less than two as low restraint (LR). An equal number of high restraint and low restraint eaters will be tested.
Three different vegetables with or without spices given a total of 6 dishes will be tested in 6 visits per subject. The order in which each participant will be presented with the spiced or plain vegetables is randomized. Participants will be presented with a tray containing one of the three different vegetables served as a buffet in containers. As each subject ingests the dish with or without spices the rate of eating and amount eaten will be measured using a computer-based system modified from the Universal Eating Monitor.
Broccoli will be seasoned with pre-prepared spice mix containing garlic powder (0.7g), onion powder (0.7g), black pepper (0.25g) and basil leaves (0.12g); cauliflower (300g) with garlic (0.1g), dill weed (0.12g), onion (0.05g) and black pepper (0.05g); and spinach (300g) with dried chervil (0.07g), dried chives (0.13g), garlic (0.4g) and onion (0.4g).
- Being tested
- Food consumption
- Keywords
- spices and vegetables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food consumptionOther
Cooked vegetables with spices or without spices
| Study group | Role | What they receive |
|---|---|---|
| Vegetable Intake with Spices Added | Experimental | Subjects consuming vegetables with mixed-spices added. Receives: Other: Food consumption |
| Vegetable Intake without Spices Added | Active comparator | Subjects consuming vegetables without spice. Receives: Other: Food consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences Between Plain and Spiced Vegetables Intake
Vegetable intake (grams) was measured while ingesting using an Universal Eating Monitor integrating a hidden weighing apparatus with specialized data collection software to analyze human eating.
Measured: 1 day
Secondary outcomes (1)
Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters
Twenty subjects were categorized based on their score on the Three-Factor Eating Questionnaire with score greater than 2 defined as high restraint (HR), and 2 or less defined as low restraint (LR) eaters.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overcoming Resistance to Eating Cruciferous VegetablesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012283
- Sponsor's protocol ID
- VEGSPICE-12-001119
- Status last verified
- Oct 2019
- First submitted
- 10 Dec 2013
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li, Z. , Krak, M. , Zerlin, A. , Brahe, L. , Rheinwald-Jones, A. , Thames, G. , Zhang, Y. , Tseng, C. and Heber, D. (2015) The Impact of Spices on Vegetable Consumption: A Pilot Study. Food and Nutrition Sciences, 6, 437-444.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Spices on Mixed Vegetable Intake Including Brassica
- ClinicalTrials.gov ID
- NCT02012283
- Acronym / sponsor ID
- VEGSPICE-12-001119
- Keywords
- spices and vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine that carefully designed spice mixtures can override any taste aversion to brassica vegetables, increase consumption of vegetable dishes which include brassica vegetables.
Detailed description
This study is to determine the liking of vegetables, intentions to consume vegetables and differences in responses in consumption of three individual vegetables including: broccoli florets, cauliflower florets, baby spinach with and without spices added by measuring: (1) the actual intake of blanched dishes of vegetables using a modified Universal Eating Monitor when dishes are eaten plain or with added spices in random order; and (2) level of eating by baseline eating restraint using the Three Factor Eating Questionnaire (TFEQ).
This study will be conducted in healthy overweight subjects (30-60 years, Body Mass Index >25 and <30). A total of 20 subjects will be recruited (10 men and 10 women). Subjects will be further stratified by whether their level of restrained eating (10 high and 10 low restraint in each group). All participants will complete a general recruitment questionnaire which incorporates the TFEQ (Stunkard \& Messick, 1985, Cappelleri 2009) along with measures of food and drink preferences and allergies. To ensure large differences in restraint between groups, subjects will be pre-selected depending on their score on the TFEQ cognitive restraint scale, with scores greater than two defined as high restraint (HR), and two or less than two as low restraint (LR). An equal number of high restraint and low restraint eaters will be tested.
Three different vegetables with or without spices given a total of 6 dishes will be tested in 6 visits per subject. The order in which each participant will be presented with the spiced or plain vegetables is randomized. Participants will be presented with a tray containing one of the three different vegetables served as a buffet in containers. As each subject ingests the dish with or without spices the rate of eating and amount eaten will be measured using a computer-based system modified from the Universal Eating Monitor.
Broccoli will be seasoned with pre-prepared spice mix containing garlic powder (0.7g), onion powder (0.7g), black pepper (0.25g) and basil leaves (0.12g); cauliflower (300g) with garlic (0.1g), dill weed (0.12g), onion (0.05g) and black pepper (0.05g); and spinach (300g) with dried chervil (0.07g), dried chives (0.13g), garlic (0.4g) and onion (0.4g).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetable Intake with Spices Added | Experimental | Other: Food consumptionSubjects consuming vegetables with mixed-spices added. |
| Vegetable Intake without Spices Added | Active comparator | Other: Food consumptionSubjects consuming vegetables without spice. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 30-60 years of age at screen.
- BMI >25 and <30
- In good health
- Eat <3 serving of vegetable per day.
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Key exclusion criteria (7 listed)
- Any history of gastrointestinal disease except for appendectomy
- Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject allergic to spice or vegetables
- Any subject who currently uses tobacco products.
- Any subject who participates in vigorous physical activity on a regular basis.
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 |
|---|---|---|
| Food consumptionCooked vegetables with spices or without spices | Other | Vegetable Intake with Spices Added, Vegetable Intake without Spices Added |
Primary outcome
Differences Between Plain and Spiced Vegetables Intake
Time frame: 1 day
Vegetable intake (grams) was measured while ingesting using an Universal Eating Monitor integrating a hidden weighing apparatus with specialized data collection software to analyze human eating.
1 secondary outcome
Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationLi, Z. , Krak, M. , Zerlin, A. , Brahe, L. , Rheinwald-Jones, A. , Thames, G. , Zhang, Y. , Tseng, C. and Heber, D. (2015) The Impact of Spices on Vegetable Consumption: A Pilot Study. Food and Nutrition Sciences, 6, 437-444.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Food consumption in people with Overcoming Resistance to Eating Cruciferous Vegetables, run by University of California, Los Angeles.
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 7 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Differences Between Plain and Spiced Vegetables Intake (time frame: 1 day). 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 NCT02012283, which also lists 1 linked publication.
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 Nov 2019.