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Human Trials

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Human Trials Gold standard : Controlled, double-blind; versus greater potential of whole food diet Vitamins/minerals/etc. for learning and behavior (Controlled ... – PowerPoint PPT presentation

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Title: Human Trials


1
  • Human Trials
  • Gold standard Controlled, double-blind versus
    greater potential of whole food diet
  • Vitamins/minerals/etc. for learning and behavior
    (Controlled, double-blind, successful, but needs
    follow-up with whole diet)
  • Mediterranean diet for the prevention of
    cardiovascular diseases (Controlled, but not
    blind uses whole foods with resounding success)

2
  • Title The Mediterranean-style diet for the
    prevention of cardiovascular diseases
  • Author(s) de Lorgeril M, Salen P
  • Source PUBLIC HEALTH NUTRITION 9 (1A) 118-123
    Sp. Iss. SI, FEB 2006
  • Abstract Objectives To discuss present
    knowledge about Mediterranean diet and
    cardiovascular diseases.
  • Design Review of existing literature.
  • Setting and Results Epidemiological studies as
    well as randomised dietary trials suggest that
    Mediterranean diet may be important in relation
    to the pathogenesis (and prevention) of CHD. For
    instance, a striking protective effect of an
    ALA-rich Mediterranean diet was reported in the
    Lyon Diet Heart Study with a 50 to 70 reduction
    of the risk of recurrence after 4 years of
    follow-up in CHD patients. According to our
    current knowledge, dietary ALA should represent
    about 0.6 to 1 of total daily energy or about 2
    g per day in patients following a Mediterranean
    diet, whereas the average intake in linoleic acid
    should not exceed 7 g per day. Supplementation
    with very-long-chain omega-3 fatty acids (about 1
    g per day) in patients following a Mediterranean
    type of diet was shown to decrease the risk of
    cardiac death by 30 and of sudden cardiac death
    by 45 in the GISSI trial.
  • Conclusions In the context of a diet rich in
    oleic acid, poor in saturated fats and low in
    omega-6 fatty acids (a dietary pattern
    characterising the traditional Mediterranean
    diet), even small doses of omega-3 fatty acids
    (about 1 g EPADHA the form of fish oil capsules
    or 2 g alpha-linolenic acid in canola oil and
    margarine) might be very protective. These data
    underline the importance of the accompanying diet
    in any dietary strategy using fatty acid
    complements.
  • Addresses de Lorgeril M (reprint author), Univ
    Grenoble 1, NVMCV, Grenoble, France
  • Univ Grenoble 1, NVMCV, Grenoble, France E-mail
    Address michel.delorgeril_at_ujf-grenoble.fr

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6
  • Diet
  • Behavior
  • Learning
  • Mental Health

7
  • Title The effect of vitamin-mineral
    supplementation on juvenile delinquency among
    American schoolchildren A randomized, double
    blind placebo-controlled trial
  • Schoenthaler SJ, Bier ID
  • JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
    6 (1) 7-17 FEB 2000
  • Abstract
  • Objectives To determine if schoolchildren, aged
    6 to 12 years, who are given low dose
    vitamin-mineral tablets will produce
    significantly less violence and antisocial
    behavior in school than classmates who are given
    placebos.
  • Design A stratified randomized, double-blind,
    placebo-controlled trial with pretest and
    posttest measures of antisocial behavior on
    school property. Settings and Subjects Two
    "working class," primarily Hispanic elementary
    schools in Phoenix, Arizona. Approximately half
    of the potential schoolchildren participated,
    i.e., 468 students aged 6 to 12 years.
  • Intervention Daily vitamin-mineral
    supplementation at 50 of the U.S. recommended
    daily allowance (RDA) for 4 months versus
    placebo. The supplement was designed to raise
    vitamin-mineral intake up to the levels currently
    recommended by the National Academy of Sciences
    for children aged 6 to 11 years.
  • Results Of the 468 students randomly assigned to
    active or placebo tablets, the 80 who were
    disciplined at least once between September 1st
    and May 1st served as the research sample. During
    intervention, the 40 children who received active
    tablets were disciplined, on average, 1 time
    each, a 47 lower mean rate of antisocial
    behavior than the 1.875 times each for the 40
    children who received placebos (95 confidence
    interval, 29 to 65, lt5.020). The children who
    took active tablets produced lower rates of
    antisocial behavior in 8 types of recorded
    infractions threats/fighting, vandalism, being
    disrespectful, disorderly conduct, defiance,
    obscenities, refusal to work or serve,
    endangering others, and non-specified offenses.

8
  • The effect of vitamin-mineral supplementation on
    the intelligence of American schoolchildren A
    randomized, double-blind placebo-controlled trial
  • Schoenthaler SJ, Bier ID, Young K, Nichols D,
    Jansenns S
  • JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
    6 (1) 19-29 FEB 2000
  • Design A double-blind, placebo-controlled trial
    using stratified randomization within each
    teacher's class based on pre-intervention
    nonverbal intelligence.
  • Settings and Subjects Two "working class,"
    primarily Hispanic, elementary schools in
    Phoenix, Arizona, participated in the study.
    Slightly more than half the teachers in each
    school distributed the tablets daily to 245
    schoolchildren aged 6 to 12 years.
  • Intervention Daily vitamin-mineral
    supplementation at 50 of the U.S. daily
    recommended allowance (RDA) for 3 months versus
    placebo.
  • Outcome Measures Post-test nonverbal IQ, as
    measured by the Wechsler Intelligence Scale for
    Children-Revised (WISC-R), while controlling for
    pretest nonverbal IQ as a covariate.
  • Four Main Results First, a significant
    difference of 2.5 IQ points (95 CI 1.85-3.15)
    was found between 125 children given active
    tablets and 120 children given placebo tablets (p
    0.038). Second, this finding is consistent with
    the mean 3.2 IQ point net gain found in the 12
    similar but less rigorous studies. Third, a
    significantly higher proportion of children in
    the active group gained 15 or more IQ points when
    compared to the placebo group (p lt 0.01). Fourth,
    although 81 matched pairs produced no difference
    at all in nonverbal IQ gain, the modest 2.5 IQ
    point net gain for the entire sample can be
    explained by the remaining 24 children who took
    active tablets, and had a 16 point higher net
    gain in IQ than the remaining 19 placebo
    controls.
  • Conclusions This study confirms that
    vitamin-mineral supplementation modestly raised
    the nonverbal intelligence of some groups of
    Western schoolchildren by 2 to 3 points but not
    that of most Western schoolchildren, presumably
    because the majority were already adequately
    nourished. This study also confirms that
    vitamin-mineral supplementation markedly raises
    the nonverbal intelligence of a minority of
    Western schoolchildren, presumably because they
    were too poorly nourished before supplementation
    for optimal brain function.

9
  • Diet
  • Learning
  • Behavior
  • Mental Health

10
ADHD Depression Autistic spectrum Schizophrenia
Sunlight / Morning light
EFAs (n-3 etc.) (some )
Vitamins E EFAs folate, E, B12 B6 C, K
Protein-rich
Minerals zinc, magnesium-B6 zinc magnesium
Plant phenolics pine bark extract
Pollutants
Stress
Infections ()
Wheat ? ? ()
Lactose/HFCS ? ? ()
11
Recommendations
  • Use olive and canola oils as major oils add some
    fish / fish oil supplements (look for high EPA
    and DHA content listed rather than just total
    omega-3)
  • Increase diversity of grains (rye, oats, barley,
    wild rice all have more favorable ratio of
    n-6n-3 than wheat and corn) or skip wheat
    altogether? Go for whole grains. (Gluten-free
    rice, corn, potatoes, oats, millet, tapioca)
  • For protein, go for poultry, fish, and wild game
    as well as all kinds of beans
  • Diet soda or less refined alternatives
  • Copious helpings of fruits and vegetables at each
    meal
  • Add plenty of herbs and spices
  • Organic choices for e.g. strawberries, spinach,
    grapes
  • Get 20 min per day (or more depending on skin
    type) of sunlight
  • Clear your schedule and practice aggressive
    stress reduction get plenty of sleep (early to
    bed and early to rise)
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