Trial Outcomes & Findings for Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat (NCT NCT02482610)

Last Updated: 2019-04-29

Results Overview

Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)

Results posted on

2019-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.	Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.	Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.	Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes.	Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.	Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose with Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes.
Overall Study STARTED	4	5	2	3	3	5
Overall Study COMPLETED	4	5	2	3	3	5
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=22 Participants Participants who were randomized to receive either Glucose, Glucose + Whole Fat Milk, or Glucose + Non-fat Milk. All participants received all three treatments in a randomized order. Each study day lasted approximately three hours and was separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants consumed a 75 g glucose solution within five minutes. Glucose + Whole Fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of whole fat milk within five minutes. Glucose + Non-fat Milk: Following baseline measurements, participants consumed 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Age, Categorical <=18 years	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 1.8 • n=22 Participants
Sex: Female, Male Female	7 Participants n=22 Participants
Sex: Female, Male Male	15 Participants n=22 Participants
Region of Enrollment United States	22 participants n=22 Participants
Body Mass Index	31.6 kg/m^2 STANDARD_DEVIATION 1.2 • n=22 Participants
Waist Circumference	107.7 cm STANDARD_DEVIATION 3.3 • n=22 Participants
Systolic Blood Pressure	125.4 mmHg STANDARD_DEVIATION 2.3 • n=22 Participants
Diastolic Blood Pressure	82.7 mmHg STANDARD_DEVIATION 1.7 • n=22 Participants
Fasting Glucose	109.8 mg/dL STANDARD_DEVIATION 1.9 • n=22 Participants
Total Cholesterol	177.7 mg/dL STANDARD_DEVIATION 7.7 • n=22 Participants
Carotid Artery Intima Media Thickness (cIMT) (left)	.59 mm STANDARD_DEVIATION .01 • n=22 Participants
Carotid Artery Intima Media Thickness (cIMT) (right)	.59 mm STANDARD_DEVIATION .01 • n=22 Participants

PRIMARY outcome

Timeframe: Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)

Outcome measures

Outcome measures
Measure	Glucose With Whole Fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.	Glucose n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.	Glucose With Non-fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Vascular Endothelial Function	-6.181 %*min Standard Error 47.2	-195.9 %*min Standard Error 35.99	-5.629 %*min Standard Error 36.92

SECONDARY outcome

Timeframe: Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min)

Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)

Outcome measures

Outcome measures
Measure	Glucose With Whole Fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.	Glucose n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.	Glucose With Non-fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Biomarker of Nitric Oxide Homeostasis (NOx)	-1240 umol/L*min Standard Error 252.7	-2229 umol/L*min Standard Error 343.3	-1221 umol/L*min Standard Error 228.3

SECONDARY outcome

Timeframe: Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min)

Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)

Outcome measures

Outcome measures
Measure	Glucose With Whole Fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Whole Fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.	Glucose n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose: Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.	Glucose With Non-fat Milk n=22 Participants This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women. Glucose with Non-fat Milk: Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
Glucose	4481 mg/dL*min Standard Error 652.4	6259 mg/dL*min Standard Error 622.5	3408 mg/dL*min Standard Error 574.7

SECONDARY outcome

Timeframe: Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min)

MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)