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Mars Flavanol Exercise and Cognitive Function Study

This study has been completed.
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01180127
First received: May 21, 2010
Last updated: January 14, 2015
Last verified: December 2014
Results First Received: December 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Basic Science
Condition: Cognitive Function
Interventions: Dietary Supplement: Flavanol containing food product
Behavioral: Aerobic training
Dietary Supplement: Food product lacking flavanol
Behavioral: Wait list control

  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
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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
Exercise, Dietary Intervention

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

no Exercise, Dietary Intervention

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Exercise, Food Additive Lacking Flavanol

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait List Control Food Additive Without Flavanol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise


Participant Flow:   Overall Study
    Exercise, Dietary Intervention     no Exercise, Dietary Intervention     Exercise, Food Additive Lacking Flavanol     Wait List Control Food Additive Without Flavanol  
STARTED     10     11     10     10  
COMPLETED     8     11     9     9  
NOT COMPLETED     2     0     1     1  



  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
Exercise, Dietary Intervention

aerobic training and flavanol containing food product

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

no Exercise, Dietary Intervention

wait list control plus flavanol containing food product for 12 weeks

Flavanol containing food product: 12 weeks, 2X/day, 20g serving

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Exercise, Food Additive Lacking Flavonol

aerobic training plus food additive without flavanol

Aerobic training: 4X/week, 1 hour/session at 75% maximum HR

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait List Control Food Additive Without Flavonol

12 weeks of wait list control status plus food additive without the flavanol containing food product

Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol

Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise

Total Total of all reporting groups

Baseline Measures
    Exercise, Dietary Intervention     no Exercise, Dietary Intervention     Exercise, Food Additive Lacking Flavonol     Wait List Control Food Additive Without Flavonol     Total  
Number of Participants  
[units: participants]
  10     11     10     10     41  
Age  
[units: years]
Mean (Standard Deviation)
  58.4  (4.9)     57.5  (5.34)     56.6  (5.56)     56.6  (3.7)     57.5  (4.89)  
Gender  
[units: participants]
         
Female     8     7     7     7     29  
Male     2     4     3     3     12  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     1     2     3     4     10  
Not Hispanic or Latino     9     9     7     6     31  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     1     0     0     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     2     2     2     7  
White     7     6     6     4     23  
More than one race     0     0     0     0     0  
Unknown or Not Reported     1     3     2     3     9  
Region of Enrollment  
[units: participants]
         
United States     10     11     10     10     41  



  Outcome Measures
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1.  Primary:   CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)   [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]

2.  Primary:   ModBent (Modified Benton Visual Retention Test)   [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]

3.  Secondary:   Modified Rey Auditory Verbal Learning Test   [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]

4.  Secondary:   VO2max   [ Time Frame: Up to 12 weeks after exercise/dietary intervention exposure ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard Sloan
Organization: Columbia University Medical Center, Division of Behavioral Medicine in Psychiatry
phone: 646-774-8940
e-mail: rps7@cumc.columbia.edu


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01180127     History of Changes
Other Study ID Numbers: 5804
Study First Received: May 21, 2010
Results First Received: December 23, 2014
Last Updated: January 14, 2015
Health Authority: United States: Institutional Review Board