Hypertension Clinical Trial
Official title:
Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors
This cross-over study investigates health effects of dietary intake of whole walnuts towards
cardiovascular risk factors in adults under low cardiovascular risk.
Investigators hypothesize that daily intake of whole nuts as a replacement meal, would
improve cardiovascular risk factors, including traditional risk factors and molecular
biomarkers.
The participants are randomly assigned to receive either study treatment, or no treatment,
and are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
Recent literature data raise important questions on the beneficial effect of dietary fats.
Dietary intake of nuts, although with high caloric burden, is however characterized with high
intake of fatty acids with known beneficial health effects. Those fatty acids include mono-
(MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are
ascribed.
Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA,
especially content of alpha-linolenic PUFA, considered essential fatty acid, since not
synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be
inversely related with cardiovascular risk factors, both in interventional studies and
epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional,
and includes the action itself, as well as beneficial endogenous conversion towards
long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.
Although high caloric intake is indicated with intake of walnuts, literature data suggest
that consumption of walnuts does not increase body weight.
Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and
apolipoproteins in adult population. Also, consumption of walnuts was associated with
decrease in blood pressure.
The study design is cross-over, controlled, randomized nutritional intervention. The
participants are randomly assigned to receive either study treatment, or no treatment, and
are crossed after five weeks.
The study subjects are instructed to continue with their habitual diet and physical activity.
Additionally, study subjects are instructed to avoid walnuts and nuts other then study
treatment, during the complete study period of 10 weeks.
Sample size calculation was conducted by use of online calculators, and was based on the low
density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in
a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2
and 0.05, respectively, 62 subjects are needed.
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