Does a Nutritional Supplement Increase Vitality, Energy and Perceived Well Being?
Condition: Healthy
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      PURPOSE To conduct a study to determine the potential benefits of All Greens.

      HYPOTHESIS Our primary hypothesis is that a greater proportion of participants on All Greens
      will score higher on the subjective scores of vitality and energy, as measured by our
      validated survey, than those consuming the control formulation.

      JUSTIFICATION 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 a well-balanced
      phytonutrient formula that nourishes, energizes, cleanses and acts as a whole body tonic.
      Recently, Boon et al (2004) have published results demonstrating some clinical benefits of
      consuming Greens+, a product similar to All Greens. After 12 weeks, women randomized to
      consume Greens+ scored marginally higher on subjective scores on Vitality and significantly
      higher on Energy than those consuming a placebo group (Boon, 2004). However, limitations of
      this study such as incomplete blinding and a high drop-out rate limit the veracity of the
      findings.

      OBJECTIVES To determine if 12 weeks of consumption of All Greens increases vitality, energy,
      and perception of well-being compared to consumption of a placebo in adult women and men
      (18-45 y).

      RESEARCH METHOD The investigators aim to recruit 120 people (18-45 y) through advertisements
      and word of mouth. In a lead-in phase, subjects will be asked to consume an 'initiation
      drink' daily for a week. The purpose of this is to identify those subjects who are unlikely
      to complete the study so they can be excluded before randomization, in order to minimize the
      dropout rate. The lead-in product will be composed primarily of rice flour, with other
      ingredients added to make it comparable to the All Greens and control formulation.

      Participants remaining after the week lead-in phase week will be asked to attend a morning
      clinic at the university. Height and weight will be recorded, health and demographic
      information will be collected by questionnaire, and outcome measure questionnaires will be
      completed. Participants will be randomized to All Greens or the control formulation. Subjects
      will be instructed to record any side effects or adverse events in a study diary. At 6 weeks,
      study staff will phone participants, to check on progress.

      Twelve weeks after randomization, participants will be asked to return to clinic to repeat
      the outcome measure questionnaires. Compliance will be assessed by weighing returned
      supplements and by patient diary. Adverse events will be recorded in the diaries. If patients
      withdraw from the study they will still be encouraged to return at 12 weeks to complete the
      outcome measures to allow for intent-to-treat analysis.

      SAMPLE SIZE The sample size estimate is based on the primary outcome. The mean score on the
      vitality subscale of the SF-36 in a large study of women was 65 with a SD of 18. A ten-point
      change in the SF-36 vitality sub-scale can be considered a "moderate" effect that is
      clinically and socially relevant. Assuming 80% power, P-value of 0.05, an SD of 18, a
      correlation between baseline and follow-up measures of at least R=0.5, 50 subjects per
      treatment group would be needed to detect a 5 point difference between the groups. Assuming
      20% attrition 120 subjects randomized would be required.

      STATISTICAL ANALYSIS Differences in outcomes measures at twelve weeks will be assessed by
      multiple regression analysis with adjustment for baseline values and other predetermined
      factors (i.e. last menstrual period, oral contraceptive use).
    

Intervention name(s): All Greens; Control Formulation
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; The Control Formulation is a rice-flour based product that has been designed to mimic the All Greens in appearance and taste.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Health; Vitality; Well-being; Nutritional Supplement; Phytonutrient; Greens