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Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
food
Sponsored by
ICAN Nutrition Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ICAN Nutrition Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Walnut-Control

Control-Walnut

Arm Description

Outcomes

Primary Outcome Measures

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.
changes of blood triglyceride level
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
changes of blood high-density lipoprotein cholesterol levels
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
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.
changes of blood glucose level
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.

Secondary Outcome Measures

changes of total cholesterol level
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
changes of serum apolipoprotein B level
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
changes of serum adiponectin level
Blood adiponectin (ug/mL) levels were measured using ELISA.
changes of serum leptin level
Blood leptin (ug/mL) levels were measured using ELISA.
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.
changes of low-density lipoprotein cholesterol level
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.

Full Information

First Posted
August 14, 2017
Last Updated
August 28, 2017
Sponsor
ICAN Nutrition Education and Research
Collaborators
California Walnut Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03267901
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ICAN Nutrition Education and Research
Collaborators
California Walnut Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walnut-Control
Arm Type
Experimental
Arm Title
Control-Walnut
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
food
Intervention Description
45 g of walnut / iso-caloric white bread
Primary Outcome Measure Information:
Title
changes of waist circumference
Description
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
Title
changes of blood triglyceride level
Description
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of blood high-density lipoprotein cholesterol levels
Description
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of blood pressure
Description
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
Title
changes of blood glucose level
Description
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
Secondary Outcome Measure Information:
Title
changes of total cholesterol level
Description
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of serum apolipoprotein B level
Description
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of serum adiponectin level
Description
Blood adiponectin (ug/mL) levels were measured using ELISA.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of serum leptin level
Description
Blood leptin (ug/mL) levels were measured using ELISA.
Time Frame
after 16 weeks of daily walnut consumption
Title
changes of serum insulin level
Description
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
Title
changes of low-density lipoprotein cholesterol level
Description
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
Time Frame
after 16 weeks of daily walnut consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
ICAN Nutrition Education and Research
City
Seoul
ZIP/Postal Code
07327
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30984354
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.
Results Reference
derived

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Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome

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