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Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier:
NCT01787591
First received: February 6, 2013
Last updated: September 30, 2016
Last verified: September 2016
Results First Received: March 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Non-alcoholic Fatty Liver
Metabolic Syndrome
Interventions: Other: Fat-Free Milk
Other: Low-Fat Milk
Other: Full-Fat Milk
Other: Soy Milk

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Acute Fat-Free Milk Ingestion First

Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.

Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.

Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Low-Fat Milk Ingestion First

Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.

Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.

Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Full-Fat Milk Ingestion First

Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.

Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.

Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.

Acute Soy Milk Ingestion First

Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.

Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.

Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.


Participant Flow for 4 periods

Period 1:   Period 1 (Cross-over Arm 1)
    Acute Fat-Free Milk Ingestion First   Acute Low-Fat Milk Ingestion First   Acute Full-Fat Milk Ingestion First   Acute Soy Milk Ingestion First
STARTED   5   5   5   6 
COMPLETED   5   5   5   5 
NOT COMPLETED   0   0   0   1 
Withdrawal by Subject                0                0                0                1 

Period 2:   Period 2 (Cross-over Arm 2)
    Acute Fat-Free Milk Ingestion First   Acute Low-Fat Milk Ingestion First   Acute Full-Fat Milk Ingestion First   Acute Soy Milk Ingestion First
STARTED   5   5   5   5 
COMPLETED   5   5   5   5 
NOT COMPLETED   0   0   0   0 

Period 3:   Period 3 (Cross-over Arm 3)
    Acute Fat-Free Milk Ingestion First   Acute Low-Fat Milk Ingestion First   Acute Full-Fat Milk Ingestion First   Acute Soy Milk Ingestion First
STARTED   5   5   5   5 
COMPLETED   5   5   5   5 
NOT COMPLETED   0   0   0   0 

Period 4:   Period 4 (Cross-over Arm 4)
    Acute Fat-Free Milk Ingestion First   Acute Low-Fat Milk Ingestion First   Acute Full-Fat Milk Ingestion First   Acute Soy Milk Ingestion First
STARTED   5   5   5   5 
COMPLETED   5   5   5   5 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Participants As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
Metabolic Syndrome Participants As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
Total Total of all reporting groups

Baseline Measures
   Healthy Participants   Metabolic Syndrome Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.3  (4)   32.8  (5.1)   31.6  (4.7) 
Gender 
[Units: Participants]
     
Female   5   5   10 
Male   5   5   10 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
 22.6  (2.2)   37.7  (9.4)   30.2  (10.2) 
Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 89.2  (6.2)   107.6  (4.2)   98.4  (13.9) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 118.8  (9.5)   128.2  (23.6)   123.5  (18.1) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 74.0  (7.9)   79.0  (10.1)   76.5  (9.2) 
Waist Circumference 
[Units: Cm]
Mean (Standard Deviation)
 75.2  (6.5)   116.1  (23.7)   95.7  (27.0) 
Triglyceride 
[Units: mg/dL]
Mean (Standard Deviation)
 82.0  (30.4)   152.7  (68.1)   117.4  (62.8) 
HDL cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 56.0  (9.9)   41.2  (10.8)   48.6  (12.6) 
alpha-tocopherol 
[Units: umol/L]
Mean (Standard Deviation)
 22.2  (3.9)   23.9  (2.8)   23.1  (3.4) 
alpha-tocopherol 
[Units: Umol/mmol lipid]
Mean (Standard Deviation)
 4.54  (0.85)   3.71  (0.85)   4.13  (0.93) 


  Outcome Measures
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1.  Primary:   Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)   [ Time Frame: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal ]

2.  Primary:   Cmax   [ Time Frame: 0-72 h post-meal ]

3.  Primary:   Tmax   [ Time Frame: 0-72 h post-meal ]

4.  Primary:   Elimination Rate   [ Time Frame: 0-72 h post-meal ]

5.  Primary:   Estimated Absorption (% Dose)   [ Time Frame: 0-72 h post-meal ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Richard S. Bruno, PhD, RD
Organization: The Ohio State University
phone: 614-292-1698
e-mail: bruno.27@osu.edu


Publications of Results:

Responsible Party: Richard Bruno, Ohio State University
ClinicalTrials.gov Identifier: NCT01787591     History of Changes
Other Study ID Numbers: 2012H0344
Study First Received: February 6, 2013
Results First Received: March 24, 2016
Last Updated: September 30, 2016
Health Authority: United States: Institutional Review Board