MedDataX Logo

Trial Outcomes & Findings for Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy (NCT NCT04056624)

NCT ID: NCT04056624

Last Updated: 2023-06-15

Results Overview

Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the skin carotenoid value at 3 weeks minus the value at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

Change in skin carotenoid status from baseline to 3 weeks

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure
Low Dose
1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids
High Dose
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids
Placebo
6 ounces of apple juice (negligible carotenoids 0.03 mg/6oz) Placebo control - Apple juice: Juice with negligible carotenoids
Overall Study
STARTED
53
56
53
Overall Study
COMPLETED
52
54
52
Overall Study
NOT COMPLETED
1
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Low Dose
1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids
High Dose
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids
Placebo
6 ounces of apple juice (negligible carotenoids 0.03 mg/6oz) Placebo control - Apple juice: Juice with negligible carotenoids
Overall Study
Withdrawal by Subject
0
0
1
Overall Study
Protocol Violation
1
2
0

Baseline Characteristics

Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Low Dose
n=53 Participants
1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids
High Dose
n=56 Participants
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids
Placebo
n=53 Participants
6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids
Total
n=162 Participants
Total of all reporting groups
Age, Continuous
33.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
32.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
31.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
32.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
27 Participants
n=7 Participants
36 Participants
n=5 Participants
83 Participants
n=4 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
29 Participants
n=7 Participants
17 Participants
n=5 Participants
79 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
14 Participants
n=5 Participants
13 Participants
n=7 Participants
13 Participants
n=5 Participants
40 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=5 Participants
15 Participants
n=7 Participants
13 Participants
n=5 Participants
41 Participants
n=4 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
15 Participants
n=7 Participants
15 Participants
n=5 Participants
44 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
n=5 Participants
13 Participants
n=7 Participants
12 Participants
n=5 Participants
37 Participants
n=4 Participants
Skin Carotenoid Level
310.8 units on a scale
STANDARD_DEVIATION 101.7 • n=5 Participants
290.2 units on a scale
STANDARD_DEVIATION 89.1 • n=7 Participants
293.6 units on a scale
STANDARD_DEVIATION 100.9 • n=5 Participants
298.0 units on a scale
STANDARD_DEVIATION 97.1 • n=4 Participants

PRIMARY outcome

Timeframe: Change in skin carotenoid status from baseline to 3 weeks

Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the skin carotenoid value at 3 weeks minus the value at baseline.

Outcome measures

Outcome measures
Measure
Low Dose
n=52 Participants
1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids
High Dose
n=54 Participants
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids
Placebo
n=52 Participants
6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids
3-week Change in Skin Carotenoid Status
28.0 units on a scale
Interval 15.6 to 40.5
62.3 units on a scale
Interval 49.6 to 74.9
9.34 units on a scale
Interval -1.14 to 19.8

PRIMARY outcome

Timeframe: Change in skin carotenoid status from baseline to 6 weeks

Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the value at 6 weeks minus the value at baseline.

Outcome measures

Outcome measures
Measure
Low Dose
n=52 Participants
1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids
High Dose
n=54 Participants
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids
Placebo
n=52 Participants
6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids
6-week Change in Skin Carotenoid Status
59.0 units on a scale
Interval 42.0 to 76.1
123 units on a scale
Interval 105.0 to 141.0
11.9 units on a scale
Interval 0.16 to 23.6

Adverse Events

Low Dose

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

High Dose

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

Placebo

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

Stephanie Jilcott Pitts

East Carolina University, Department of Public Health

Phone: 252-744-5572

Results disclosure agreements

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