NCT01752868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2011

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

December 14, 2012

Last Update Submit

December 14, 2012

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Carotid-femoral pulse wave velocity

    Baseline and 6 months

Study Arms (2)

supplement

EXPERIMENTAL
Dietary Supplement: Supplement

control

NO INTERVENTION

Interventions

SupplementDIETARY_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.

supplement

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Luigi Fontana, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 19, 2012

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

US(1)