NCT01665469

Brief Summary

The hypothesis of the study is that tomato extracted lycopene will be able to decrease postprandial oxidation and inflammation in healthy weight men and women when compared to Placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

August 9, 2012

Last Update Submit

December 21, 2017

Conditions

Postprandial Oxidation and inflammation

Keywords

anti oxidationlycopeneOx-LDL

Outcome Measures

Primary Outcomes (1)

  • Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene

    Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.

    Baseline and over 6 hours

Secondary Outcomes (1)

  • Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene

    Baseline and over 6 hours

Other Outcomes (2)

  • Correlation between the anti-oxidation and anti-inflammation effects and serum lycopene, phytofluene and phytoene levels

    Baseline and over 6 hours

  • Number of adverse events recorded during the supplementation period, lycopene compared to placebo

    2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Soft gel capsule without test material

Dietary Supplement: Placebo

Tomato extracted lycopene

EXPERIMENTAL

Soft gel cups for oral use

Dietary Supplement: Tomato extracted lycopene

Interventions

Tomato extracted lycopeneDIETARY_SUPPLEMENT
Tomato extracted lycopene
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age: 21 - 70 years both inclusive
  • Subject with Body Mass Index: 19- 25 kg/m2 both inclusive
  • Subject with Fasting serum LDL-cholesterol: ≥ 100 mg/dL and \< 200 mg/dL
  • Subject with High-sensitivity C-reactive protein (hsCRP) \< 1.0 mg/L
  • Subject is willing to take supplement once daily for 4 weeks and undergo other study-related procedures
  • Subject is otherwise is in general good health as determined by the principal investigator
  • Subjects is willing to sign an informed consent form prior to joining the study

You may not qualify if:

  • Subjects suffering from overweight defined as BMI \> 25 kg/m2
  • Subject that is actively losing weight (e.g. are on a diet) or subjects with greater than 5% change in body weight within 1 month prior to the randomization visit
  • Subject taking lipid-altering drug therapy within six weeks prior to screening. Also excluded are supplements known to have significant lipid altering effects, such as niacin, garlic, omega-3 fatty acids, red yeast rice extract, phytostanols / phytosterols, soluble fiber, chitosan and conjugated linoleic acid
  • Subjects using the following medications: systemic corticosteroids, orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy
  • Subjects that will not be able to follow dietary proscriptions from the screening visit through the final visit
  • Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
  • Subjects with known allergy to tomato, carotenoids, or vitamin E
  • Subjects that has high fasting serum triglyceride
  • Subjects that has a diagnosis of type 1 or type 2 diabetes mellitus
  • Subjects that has high serum thyroid-stimulating hormone
  • Subjects that has aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal
  • Subjects that has Creatinine ≥ 1.5 mg/dl
  • Subjects that has high-sensitivity C-reactive protein
  • Woman subjects with positive pregnancy test
  • Woman subjects that are breast feeding, pregnant, or planning on becoming pregnant during the duration of the study
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Links

Study Officials

  • David Zeltser, Prof'

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 15, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

December 22, 2017

Record last verified: 2017-12

Locations

IL(1)