NCT01427426

Brief Summary

Factors Group is a producer of nutritional supplements. This study aims to determine whether one of their products improves the energy and sense of well-being in individuals who consume it. Interested subjects will complete a 1 week lead-in phase where they will be asked to consume a placebo daily to see if they are a good fit for the study. After the lead-in phase, subjects will be randomized to take either All Greens or a different placebo for 12 weeks. The investigators expect All Greens to have better results than the placebo, but subjects will not know which supplement they are taking. The primary outcome is a score on a questionnaire of well being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4 healthy

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 5, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

August 5, 2011

Last Update Submit

March 14, 2014

Conditions

Healthy

Keywords

HealthVitalityWell-beingNutritional SupplementPhytonutrientGreens

Outcome Measures

Primary Outcomes (1)

  • Change in score on the Short-Form 36 (SF-36)

    The Short Form-36 (SF-36) is a validated, multi-purpose, short-form health survey that is a generic measure of health status/quality of life. It provides an overall measure of physical and mental health, as well as eight subscale profiles, of which three were considered to be relevant for this study: general health, vitality, and mental health. The SF-36 is licensed by the company QualityMetric.

    Baseline and Study End (12 weeks after randomization)

Secondary Outcomes (3)

  • Change in scores on 10 cm Visual Analogue Scales (VAS)

    Randomization and 12 weeks (study end)

  • Number of participants who report side effects

    From enrollment to 13 weeks (study end)

  • Number of unused supplement packets

    Enrollment to 13 weeks (study end)

Study Arms (2)

All Greens

EXPERIMENTAL

Subjects will consume the All Greens product daily. Product is prepared by mixing with either water, juice or in a smoothie.

Dietary Supplement: All Greens

Control formulation

SHAM COMPARATOR

Subjects will consume a product of similar consistency and comparable taste that does not have the same healthy ingredients as the All Greens.

Other: Control Formulation

Interventions

All GreensDIETARY_SUPPLEMENT

All Greens is a mixture of organic alfalfa powder, barley, wheat grass juice powder, lycopene, cranberry juice extract, rosehips, grapeseed phytosomes, soya extract, Acidophilus, bromelain, apple pectin, and other ingredients. All Greens is approved by Health Canada and available to the public for purchase.

All Greens
Control FormulationOTHER

The Control Formulation is a rice-flour based product that has been designed to mimic the All Greens in appearance and taste.

Control formulation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not taking any other nutritional supplement (including fish oils, vitamins...) or be willing to discontinue use for duration of study

You may not qualify if:

  • Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, a history of kidney stones or psychiatric illness.
  • Currently taking antidepressants, anticoagulant or other medications that may interact with the nutritional supplement.
  • Unable to provide informed consent
  • Women who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

  • Boon H, Clitheroe J, Forte T. Effects of greens+: a randomized, controlled trial. Can J Diet Pract Res. 2004 Summer;65(2):66-71. doi: 10.3148/65.2.2004.66.

    PMID: 15217524BACKGROUND

Study Officials

  • Timothy J Green, PhD

    University of British Columbia, Department of Food, Nutrition and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

September 1, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

CA(1)