Trial Outcomes & Findings for The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension (NCT NCT00979732)

Last Updated: 2021-02-11

Results Overview

BP was monitored using ambulatory BP monitors (Ambulo2400; Tiba Medical, Inc.) that were programmed to take BP measurements automatically at 1-h intervals for a period of 24 h. BP measurements were scheduled at week 0 and 6 of the intervention (for efficacy assessment). Day-time BP and night-time BP were divided based on the subject's sleeping hours and hours awake.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-02-11

Participant Flow

The study was performed at the Clinical Nutrition Research Center at the Illinois Institute of Technology (Chicago, IL, USA) from 2010 to 2014.

Eligible subjects started with a 2-week run-in period drinking the Placebo beverage twice per day. After the 2-week run-in period, subjects were randomised to one of the two groups (Placebo or GSE beverage), equally allocated to each treatment (1:1 randomisation ratio).

Participant milestones

Participant milestones
Measure	GSE Beverage Active grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form	GSE Beverage Placebo grape seed extract placebo beverage 150 mg/BID grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Overall Study STARTED	15	18
Overall Study COMPLETED	12	17
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSE Beverage Active n=12 Participants grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form	GSE Beverage Placebo n=17 Participants grape seed extract placebo beverage 150 mg/BID grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form	Total n=29 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 10 • n=5 Participants	42 years STANDARD_DEVIATION 10 • n=7 Participants	43 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 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
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	17 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All completers

Outcome measures

Outcome measures
Measure	GSE Beverage Active n=12 Participants grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form	GSE Beverage Placebo n=17 Participants grape seed extract placebo beverage 150 mg/BID grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Systolic Blood Pressure	118 mmHg Standard Error 2.3	127 mmHg Standard Error 1.9

SECONDARY outcome

Timeframe: 6 weeks

Population: All completer

After 10-12 h of overnight fasting, fasting blood samples were collected at week 0 (baseline) and week 3 and 6 of the intervention. plasma insulin were evaluated.

Outcome measures

Outcome measures
Measure	GSE Beverage Active n=12 Participants grape seed extract beverage 150 mg/BID grape seed extract: grape seed extract 150 mg twice a day (BID) in beverage or capsule form	GSE Beverage Placebo n=17 Participants grape seed extract placebo beverage 150 mg/BID grape seed extract placebo: grape seed extract 150 mg twice a day (BID) in beverage or capsule form
Plasma Insulin Level Over 6 Weeks	17.8 µIU/mL Standard Error 1.5	20.9 µIU/mL Standard Error 1.2

Adverse Events

GSE Beverage Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GSE Beverage 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

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