An interventional study of food in Metabolic Syndrome, sponsored by ICAN Nutrition Education and Research. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by ICAN Nutrition Education and Research · Not applicable, Interventional, and Treatment
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
Inclusion Criteria: at least three out of five metabolic syndrome components
Exclusion Criteria:
Other: food
Other: food
45 g of walnut / iso-caloric white bread
changes of waist circumference
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
Time frame: after 16 weeks of daily walnut consumption
changes of blood triglyceride level
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
Time frame: after 16 weeks of daily walnut consumption
changes of blood high-density lipoprotein cholesterol levels
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
Time frame: after 16 weeks of daily walnut consumption
changes of blood pressure
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
Time frame: after 16 weeks of daily walnut consumption
changes of blood glucose level
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
Time frame: after 16 weeks of daily walnut consumption
changes of total cholesterol level
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
Time frame: after 16 weeks of daily walnut consumption
changes of serum apolipoprotein B level
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
Time frame: after 16 weeks of daily walnut consumption
changes of serum adiponectin level
Blood adiponectin (ug/mL) levels were measured using ELISA.
Time frame: after 16 weeks of daily walnut consumption
changes of serum leptin level
Blood leptin (ug/mL) levels were measured using ELISA.
Time frame: after 16 weeks of daily walnut consumption
changes of serum insulin level
Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
Time frame: after 16 weeks of daily walnut consumption
changes of low-density lipoprotein cholesterol level
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
Time frame: after 16 weeks of daily walnut consumption
Plan to share: Undecided
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ICAN Nutrition Education and Research