Trial Outcomes & Findings for A Study of Strawberries and Disease Risk (NCT NCT01199848)

NCT ID: NCT01199848

Last Updated: 2021-02-12

Results Overview

Strawberry dose-response effect on Postprandial glycemic control in insulin resistant individuals.plasma insulin concentration is measured over 6 hours by Randox clinical analyzer, analyzed with SAS mixed model.

Recruitment status

COMPLETED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

6 hour postprandial study over 4 periods

Results posted on

2021-02-12

Participant Flow

The study was conducted in Chicago, IL, USA from September 2010 to January 2013.

7-day pre-study period: Following the screening visit, qualified subjects were asked to record their usual diet intake for 3 days, including 2 weekdays and 1 weekend day in order to know their usual intake and to coach them on what foods in their diet are rich in polyphenolics, especially 3 days prior to their each study visit.

Participant milestones

Participant milestones
Measure	All Study Participants All participants received all 4 interventions (Placebo, STRB 10g, STRB 20g, and STRB 40g) in a randomized sequence Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal Dose 1-10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal Dose 2- 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal Dose 3-40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
Placebo Arm STARTED	29
Placebo Arm COMPLETED	21
Placebo Arm NOT COMPLETED	8
10g STR Arm STARTED	21
10g STR Arm COMPLETED	21
10g STR Arm NOT COMPLETED	0
20G STRB Arm STARTED	21
20G STRB Arm COMPLETED	21
20G STRB Arm NOT COMPLETED	0
40G STRB Arm STARTED	21
40G STRB Arm COMPLETED	21
40G STRB Arm NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Strawberries and Disease Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=21 Participants All participants received all 4 interventions (Placebo, STRB 10g, STRB 20g, and STRB 40g) in a randomized sequence Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal Dose 1-10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal Dose 2- 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal Dose 3-40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
Age, Continuous	39.8 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hour postprandial study over 4 periods

Population: study completer who finished all 4 treatments.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Pbo Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal	10G STRB Powder n=21 Participants Dose 1 10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal	20G STRB Powder n=21 Participants Dose 2 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal	40G STRB Powder n=21 Participants Dose 3 40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
Postprandial Insulin Levels for 6 Hours	63.9 microIU/mL Standard Error 5.6	64.3 microIU/mL Standard Error 5.6	60.2 microIU/mL Standard Error 5.6	56.3 microIU/mL Standard Error 5.6

SECONDARY outcome

Timeframe: 6 hours postprandial study over 4 periods(treatments)

Postprandial plasma Ox-LDL concentration was measured by ELISA method. Normalizing responses to subjects own baseline (Time 0) was analyzed by SAS mixed model.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Pbo Placebo: whole milk shake without strawberry powder served with the high fat/carbohydrate test meal	10G STRB Powder n=21 Participants Dose 1 10G: whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal	20G STRB Powder n=21 Participants Dose 2 20G: whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal	40G STRB Powder n=21 Participants Dose 3 40G: whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
Strawberry Dose-response Effect on Postprandial Oxidative Stress (Ox-LDL) in Insulin-resistant Men and Women in an Acute Postprandial Paradigm	-0.1 U/L Standard Error 0.8	-0.3 U/L Standard Error 0.8	-3 U/L Standard Error 0.8	-0.17 U/L Standard Error 0.8

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10G STRB Powder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20G STRB Powder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

40G STRB Powder

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

Britt Burton-Freeman

Illinois Institute of Techology

Phone: 708-341-0178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place