Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267901
• Other study ID #: CWC-2016-MetS
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 28, 2017
• Start date: May 1, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: ICAN Nutrition Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• food
45 g of walnut / iso-caloric white bread

Locations

Country	Name	City	State
Korea, Republic of	ICAN Nutrition Education and Research	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
ICAN Nutrition Education and Research	California Walnut Commission

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after 16 weeks of daily walnut consumption
Primary	changes of blood triglyceride level	Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.	after 16 weeks of daily walnut consumption
Primary	changes of blood high-density lipoprotein cholesterol levels	High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.	after 16 weeks of daily walnut consumption
Primary	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.	after 16 weeks of daily walnut consumption
Primary	changes of blood glucose level	Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.	after 16 weeks of daily walnut consumption
Secondary	changes of total cholesterol level	Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.	after 16 weeks of daily walnut consumption
Secondary	changes of serum apolipoprotein B level	Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.	after 16 weeks of daily walnut consumption
Secondary	changes of serum adiponectin level	Blood adiponectin (ug/mL) levels were measured using ELISA.	after 16 weeks of daily walnut consumption
Secondary	changes of serum leptin level	Blood leptin (ug/mL) levels were measured using ELISA.	after 16 weeks of daily walnut consumption
Secondary	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.	after 16 weeks of daily walnut consumption
Secondary	changes of low-density lipoprotein cholesterol level	Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.	after 16 weeks of daily walnut consumption