NCT02012283

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

December 10, 2013

Results QC Date

September 14, 2018

Last Update Submit

October 18, 2019

Conditions

Keywords

spices and vegetables

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters

    1 day

Study Arms (2)

Vegetable Intake with Spices Added

EXPERIMENTAL

Subjects consuming vegetables with mixed-spices added.

Other: Food consumption

Vegetable Intake without Spices Added

ACTIVE COMPARATOR

Subjects consuming vegetables without spice.

Other: Food consumption

Interventions

Cooked vegetables with spices or without spices

Vegetable Intake with Spices AddedVegetable Intake without Spices Added

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-60 years of age at screen.
  • BMI \>25 and \<30
  • In good health
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

Results Point of Contact

Title
Zhaoping Li, Professor
Organization
Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Zhaoping Li

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 16, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 4, 2019

Results First Posted

October 2, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share