NCT01959646

Brief Summary

This is a nutritional intervention study using healthy overweight/obese humans to investigate if a supplement made from aged garlic extract has an impact on immunity. Following a baseline blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which time a second blood draw will occur. Tests for immune function and inflammation will be performed on both the baseline and 42 day samples. The investigators anticipate that the immune functions and biomarkers that are inflammatory in an overweight/obese population will be returning to normal after 42 days of consumption of this supplement. The investigators predict that AGE supplementation will benefit immunity and improve function while reducing inflammation in a stressed population (inflamed obese).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

October 8, 2013

Last Update Submit

February 25, 2016

Conditions

Healthy

Keywords

Immune FunctionAged Garlic ExtractSupplementationInflammation

Outcome Measures

Primary Outcomes (1)

  • Markers of immune health

    Number and function of gamma delta T-cells and monocytes

    6 weeks

Secondary Outcomes (1)

  • Markers of inflammation

    6 weeks

Other Outcomes (1)

  • Serum antioxidant status (compliance)

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Group

Other: Standard for GroupsDietary Supplement: Placebo

Aged Garlic Extract Supplementation

EXPERIMENTAL

Aged Garlic Extract Supplementation Group

Dietary Supplement: Aged Garlic Extract Supplementation GroupOther: Standard for Groups

Interventions

Aged Garlic Extract Supplementation GroupDIETARY_SUPPLEMENT

Subjects will be asked to consume three (3) capsules of 600 mg aged garlic extract (AGE) with food twice a day, for a total of 3.6 grams per day.

Also known as: AGE
Aged Garlic Extract Supplementation
Standard for GroupsOTHER

To assess for eligible study participants, the research team will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually.

Aged Garlic Extract SupplementationPlacebo
PlaceboDIETARY_SUPPLEMENT

Participants will be asked to consume three (3) placebo capsules with food twice a day.

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 25-65
  • BMI \> or = to 30 kg/m2
  • willing to discontinue dietary supplements
  • cRP between 2 and 10 mg/L

You may not qualify if:

  • medication for hypertension, high cholesterol, heart failure, angina, etc
  • diagnoses of diabetes, metabolic syndrome, arthritis, severe allergies, or any other compromised immune condition
  • blood pressure \> 135/85 mmHg
  • serum triglycerides \> 150 mg/dl
  • HDL cholesterol \< 40 mg/dl for men or \< 50 mg/dl for women
  • fasting glucose \> 110 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Food Science & Human Nutrition Building, University of Florida

Gainesville, Florida, 32611, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Xu C, Mathews AE, Rodrigues C, Eudy BJ, Rowe CA, O'Donoughue A, Percival SS. Aged garlic extract supplementation modifies inflammation and immunity of adults with obesity: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr ESPEN. 2018 Apr;24:148-155. doi: 10.1016/j.clnesp.2017.11.010. Epub 2018 Jan 3.

    PMID: 29576354DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Susan Percival, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

US(2)