Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome

NCT03267901 | Completed

• 1 other identifier: CWC-2016-MetS
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

• changes of blood triglyceride level

  Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.

  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.

  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.

  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.

  after 16 weeks of daily walnut consumption

Secondary Outcomes (6)

• changes of total cholesterol level

  after 16 weeks of daily walnut consumption

• changes of serum apolipoprotein B level

  after 16 weeks of daily walnut consumption

• changes of serum adiponectin level

  after 16 weeks of daily walnut consumption

• changes of serum leptin level

  after 16 weeks of daily walnut consumption

• changes of serum insulin level

  after 16 weeks of daily walnut consumption

Study Arms (2)

Walnut-Control

EXPERIMENTAL

Other: food

Control-Walnut

EXPERIMENTAL

Other: food

Interventions

food OTHER

45 g of walnut / iso-caloric white bread

Control-Walnut; Walnut-Control

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ICAN Nutrition Education and Research: lead
• California Walnut Commission: collaborator

Study Sites (1)

ICAN Nutrition Education and Research

Seoul, 07327, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30984354 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Food

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 30, 2017
• Study Start: May 1, 2015
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

KR (1)