Can Fish Oil and Phytochemical Supplements Mimic Anti-Agi... | NCT01752868

Studies
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?

NCT01752868

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Dec 19, 2012Estimated

Enrollment

56Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 14, 2012

First Submission Date that Met QC Criteria

Dec 14, 2012

First Posted Date

Dec 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2012

Last Update Posted Date

Dec 19, 2012Estimated

Name	Class
Barnes-Jewish Hospital	OTHER

Description Module

Brief Summary

The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
supplement	Experimental		Dietary Supplement: Supplement
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplement	Dietary Supplement	Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Carotid-femoral pulse wave velocity		Baseline and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 40-60 yr
body mass index of 21 - 30 kg/m2
sedentary to moderately active
eating a typical US diet

Exclusion Criteria:

history of any chronic disease other than mild osteoarthritis
use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives
use of nutritional supplements
smoking
alcohol intake greater than two drinks per day for women and three drinks per day for men

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luigi Fontana, MD, PhD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University Medical Center		St Louis	Missouri	63110	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided