Trial Outcomes & Findings for Influence of Spices on Mixed Vegetable Intake Including Brassica Vegetables (NCT NCT02012283)

NCT ID: NCT02012283

Last Updated: 2019-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 day

Results posted on

2019-11-04

Participant Flow

The enrollment period was 11/2012 - 6/2013. The enrollment took place in a private setting the clinic located at the site.

Twenty subjects completed a general recruitment questionnaire were recruited. They were categorized based on their score on the Three-Factor Eating Questionnaire with score greater than 2 defined as high restraint eaters, and 2 or less defined as low restraint eaters. First Intervention was broccoli, second was cauliflower and third was spinach.

Participant milestones

Participant milestones
Measure
No Spice First, Then Spice
Subjects receiving plain vegetable, then vegetable with spices added
Spice First, Then no Spice
Subjects receiving vegetable with mixed-spices added, then plain vegetable
First Intervention
STARTED
10
10
First Intervention
COMPLETED
10
10
First Intervention
NOT COMPLETED
0
0
Second Intervention
STARTED
10
10
Second Intervention
COMPLETED
10
10
Second Intervention
NOT COMPLETED
0
0
Third Intervention
STARTED
10
10
Third Intervention
COMPLETED
10
10
Third Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influence of Spices on Mixed Vegetable Intake Including Brassica Vegetables

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
No Spice First, Then Spice
n=10 Participants
Subjects consumed each vegetable without spice first and then with spice mix added
Spice First, Then No Spice
n=10 Participants
Subjects consumed each vegetable with spice mix added first and then without spice
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: One female low restraint eater produced irregular data that was removed from analysis population. One male high restraint eater data was removed too to obtain equal number.

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.

Outcome measures

Outcome measures
Measure
Vegetable Intake With and Without Spices
n=18 Participants
The amount of vegetable consumed with or without spices.
Broccoli Intake Among Low Restraint Eaters
Broccoli intake with or without spices in low restraint eaters.
Differences Between Plain and Spiced Vegetables Intake
Broccoli without spice
134.1 gram
Standard Deviation 104.0
Differences Between Plain and Spiced Vegetables Intake
Broccoli with spice
212.5 gram
Standard Deviation 155.3
Differences Between Plain and Spiced Vegetables Intake
Cauliflower without spice
204.8 gram
Standard Deviation 159.2
Differences Between Plain and Spiced Vegetables Intake
Cauliflower with spice
178.1 gram
Standard Deviation 119.9
Differences Between Plain and Spiced Vegetables Intake
Spinach without spice
146.0 gram
Standard Deviation 167.9
Differences Between Plain and Spiced Vegetables Intake
Spinach with spice
118.7 gram
Standard Deviation 105.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Vegetable Intake With and Without Spices
n=9 Participants
The amount of vegetable consumed with or without spices.
Broccoli Intake Among Low Restraint Eaters
n=9 Participants
Broccoli intake with or without spices in low restraint eaters.
Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters
without spice
141.7 grams
Standard Deviation 122.2
126.4 grams
Standard Deviation 89.1
Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters
with spices added
270.8 grams
Standard Deviation 186.9
154.2 grams
Standard Deviation 93.0

Adverse Events

Broccoli With Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Broccoli No Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cauliflower With Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cauliflower No Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spinach With Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spinach No Spices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhaoping Li, Professor

Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine

Phone: 310-206-1987

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place