Influence of Spices on Mixed Vegetable Intake Including Brassica Vegetables

October 18, 2019 updated by: Zhaoping Li, University of California, Los Angeles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 30-60 years of age at screen.
  2. BMI >25 and <30
  3. In good health
  4. Eat <3 serving of vegetable per day.

c. 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.

-

Exclusion Criteria:

  1. Any history of gastrointestinal disease except for appendectomy
  2. 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.
  3. Any subject allergic to spice or vegetables
  4. Any subject who currently uses tobacco products.
  5. Any subject who participates in vigorous physical activity on a regular basis.

  6. Any subject who is unable or unwilling to comply with the study protocol.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vegetable Intake with Spices Added
Subjects consuming vegetables with mixed-spices added.
Other: Food consumption
Cooked vegetables with spices or without spices
Active Comparator: Vegetable Intake without Spices Added
Subjects consuming vegetables without spice.
Other: Food consumption
Cooked vegetables with spices or without spices

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VEGSPICE-12-001119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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