Korean Diet Efficacy Clinical Trial

NCT01124071 | Unknown

• 1 other identifier: 11-2009/12124
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To determine:

1. 1.the acceptability of a Korean diet to an Australian overweight and obese population
2. 2.which Korean recipes are easily prepared
3. 3.the effect of a Korean diet on weight, blood pressure, and metabolic complications of obesity in this population.

Conditions

Obesity

Keywords

Korean Diet

Outcome Measures

Primary Outcomes (2)

• 1. To investigate the acceptability of a Korean diet in overweight and obese Australians.

  This will be determined at baseline and 4 week timepoints throughout the study by participants completing a Food Acceptability Questionnaire (FAQ). The FAQ addresses 10 components of food acceptability along a 7-point Likeart scale. The FAQ is a recognised instrument for testing food acceptability.

  13 weeks

• 2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians.

  This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.

  13 weeks

Secondary Outcomes (1)

• To investigate changes in a number of indicators of metabolic disease in both groups - including anthropometry, Blood Glucose Levels, insulin sensitivity, lipid profiles, liver function, hormone function and inflammatory markers.

  13 weeks

Study Arms (2)

Korean Diet

ACTIVE COMPARATOR

Provision of 2 Korean meals per day, 6 days per week

Behavioral: Provision of 2 Korean meals per day 6 days per week

Western Diet

ACTIVE COMPARATOR

Lifestyle counseling, dietary advice, grocery vouchers

Behavioral: Western Diet

Interventions

Provision of 2 Korean meals per day 6 days per week BEHAVIORAL

At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Korean diet group will pick up lunch and evening meals Monday-Friday. Raw ingredients and cooking instructions will also be provided on friday for saturday meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.

Korean Diet

Western Diet BEHAVIORAL

At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Western diet group will be provided with a Western recipe cookbook and food vouchers (weekly) to purchase the necessary ingredients for the Western meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.

Western Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents of metropolitan Sydney
• Aged 18-65 years
• BMI 25-45kg/m2

You may not qualify if:

• Diabetes treated with oral medications or insulin
• Unstable angina or recent onset of cardiovascular disease
• Serious hepatic or renal disease
• serum transaminases (ALT or AST) \> 2.5 times upper limit of normal
• serum creatinine \> 1.5 times upper limit of normal or urinary microalbumin \>40 mg/L or eGFR \< 60ml/min/1.73m²
• Alcohol or illicit drug abuse
• Pregnant, breastfeeding, or planning pregnancy during the study
• Serious gastrointestinal disease (inflammatory bowel disease, active peptic ulcer, recent helicobacter pylori treatment)
• Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. some anti-psychotics, anti-depressants, or corticosteroids
• Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment
• Participation in another weight loss clinical trial within past 3 months
• Individuals who have lost \>10% weight within past 3 months
• Vegetarian eating practices
• Inability to cook or lack of facilities for home cooking
• Inability to read and write English

Sponsors & Collaborators

• University of Sydney: lead
• Inje University: collaborator
• Korea Agro-Fisheries Trade Corporation, Seoul, Korea: collaborator
• Ministry for Food, Agriculture, Forestry and Fisheries, Korea: collaborator

Study Sites (1)

The University of Sydney

Sydney, New South Wales, 2006, Australia

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, Western

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 14, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: April 1, 2011
• Last Updated: May 14, 2010

Record last verified: 2010-04

Locations

AU (1)