Clinical trial NCT03267901: Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
Official title: Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: ICAN Nutrition Education and Research
Sponsor class: INDUSTRY
Collaborators: name: California Walnut Commission
First posted: 2017-08-30
Enrollment: 119
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria: at least three out of five metabolic syndrome components

* waist circumference (WC) \>90 cm for men and \>80 cm for women
* hypertension (DBP ≥85 and \<110 mm Hg)
* hyperglycemia (≥100 mg/dL)
* elevated plasma TG concentrations (≥150 mg/dL)
* decreased plasma HDL-C concentrations (\<40 mg/dL for men and \<50 mg/dL for women)

Exclusion Criteria:

* the presence of morbid obesity (BMI ≥40)
* the use of any medication for the control of blood pressure, glucose, or lipid metabolism
* a medical history of hypocaloric diet consumption within the past year
* gastrointestinal tract disorders
* post-menopausal women
* smokers

Primary outcomes:
measure: changes of waist circumference
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of blood triglyceride level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of blood high-density lipoprotein cholesterol levels
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of blood pressure
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of blood glucose level
timeFrame: after 16 weeks of daily walnut consumption
Secondary outcomes:
measure: changes of total cholesterol level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of serum apolipoprotein B level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of serum adiponectin level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of serum leptin level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of serum insulin level
timeFrame: after 16 weeks of daily walnut consumption
measure: changes of low-density lipoprotein cholesterol level
timeFrame: after 16 weeks of daily walnut consumption
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ICAN Nutrition Education and Research
Study officials:
References:
citation: Hwang HJ, Liu Y, Kim HS, Lee H, Lim Y, Park H. Daily walnut intake improves metabolic syndrome status and increases circulating adiponectin levels: randomized controlled crossover trial. Nutr Res Pract. 2019 Apr;13(2):105-114. doi: 10.4162/nrp.2019.13.2.105. Epub 2019 Feb 11.