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Trial record 57 of 729 for:    Area Under Curve AND Bioavailability

Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat

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ClinicalTrials.gov Identifier: NCT02482610
Recruitment Status : Completed
First Posted : June 26, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Prediabetes
Interventions Other: Glucose
Other: Glucose with Whole Fat Milk
Other: Glucose with Non-fat Milk
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 4 5 2 3 3 5
Completed 4 5 2 3 3 5
Not Completed 0 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
31.7  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
7
  31.8%
Male
15
  68.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants
31.6  (1.2)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 22 participants
107.7  (3.3)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 22 participants
125.4  (2.3)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 22 participants
82.7  (1.7)
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 22 participants
109.8  (1.9)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 22 participants
177.7  (7.7)
Carotid Artery Intima Media Thickness (cIMT) (left)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 22 participants
.59  (.01)
[1]
Measure Description: cIMT was assessed as a potential co-variate by measuring cIMT using ultrasonography
Carotid Artery Intima Media Thickness (cIMT) (right)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 22 participants
.59  (.01)
[1]
Measure Description: cIMT was assessed as a potential co-variate by measuring cIMT using ultrasonography
1.Primary Outcome
Title Vascular Endothelial Function
Hide Description 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)
Time Frame Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucose Glucose With Whole Fat Milk Glucose With Non-fat Milk
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: %*min
-195.9  (35.99) -6.181  (47.2) -5.629  (36.92)
2.Secondary Outcome
Title Biomarker of Nitric Oxide Homeostasis (NOx)
Hide Description 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)
Time Frame Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucose Glucose With Whole Fat Milk Glucose With Non-fat Milk
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: umol/L*min
-2229  (343.3) -1240  (252.7) -1221  (228.3)
3.Secondary Outcome
Title Glucose
Hide Description 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)
Time Frame Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucose Glucose With Whole Fat Milk Glucose With Non-fat Milk
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: mg/dL*min
6259  (622.5) 4481  (652.4) 3408  (574.7)
4.Secondary Outcome
Title Oxidative Stress Biomarker (Malondialdehyde; MDA)
Hide Description 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)
Time Frame Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucose Glucose With Whole Fat Milk Glucose With Non-fat Milk
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: umol/L*min
54.9  (7.653) 25.78  (9.505) 31.3  (5.283)
Time Frame Participants were monitored for adverse events during the entirety of the study duration (~6 total weeks).
Adverse Event Reporting Description Participants completed a cross-over trial that examined blood vessel function and related biomarkers in response to a single controlled meal. The risk for all-cause mortality relating to the study is perceived to be zero.
 
Arm/Group Title Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

All-Cause Mortality
Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glucose, Then Glucose +Non-fat Milk, Then Glucose + Whole Milk Glucose, Then Glucose + Whole Milk, Then Glucose +Non-fat Milk Glucose +Non-fat Milk, Then Glucose + Whole Milk, Then Glucose Glucose +Non-fat Milk, Then Glucose, Then Glucose + Whole Milk Glucose + Whole Milk, Then Glucose, Then Glucose +Non-fat Milk Glucose + Whole Milk, Then Glucose +Non-fat Milk, Then Glucose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Bruno, PhD, RD
Organization: The Ohio State University
Phone: 6142925522
EMail: bruno.27@osu.edu
Other Publications:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
Layout table for additonal information
Responsible Party: Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier: NCT02482610     History of Changes
Other Study ID Numbers: 2015H0088B
First Submitted: June 24, 2015
First Posted: June 26, 2015
Results First Submitted: March 28, 2018
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019