Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001001987
Ethics application status
Approved
Date submitted
17/09/2011
Date registered
20/09/2011
Date last updated
20/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
High fruit and vegetable diet reduces metabolic inflammation
Scientific title
Diets rich in fruits and vegetables suppress blood biomarkers of metabolic stress in overweight women: A 2 x 2 metabolic diet intervention trial
Secondary ID [1] 263042 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 270775 0
Condition category
Condition code
Diet and Nutrition 270957 270957 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1: High fruit and vegetable diet (12 servings/day)
Phase 2:Low fruit and vegetable diet (2 servings/day)

The study consisted of two dietary intervention phases, and the subjects participated in both interventions. Each dietary intervention lasted for 2 weeks and was separated by 2 weeks of wash-out period.


Low-VF diet was composed of common foods providing 1 serving of vegetable and 1 serving of fruit each day. High-VF diet provided a total of 12 servings including 6 servings of vegetable and 6 servings of fruit. The composition of vegetable and fruit in high-VF diet consisted of 2 servings of dark green vegetable (e.g., spinach, broccoli, watercress); 2 servings of dark orange vegetable (e.g., carrots, sweet potatos); 2 servings of dark red product (e.g., watermelon, tomato); 2 servings of other vegetables (e.g., cruciferous vegetables, bracken, lotus root, burdock); 2 servings of vitamin C-rich fruits/juices (e.g., orange, strawberries); 2 servings of other fruits (e.g., grapes, bananas, peaches, kiwi). During the low-VF diet period, all subjects were supplied with dietary fiber powder, which corresponded to the fiber content of the vegetables and fruits supplied with high-VF diet period to maintain dietary fiber intake identical between two intervention diets since we aimed to evaluate the efficacy exerted by phytochemicals contained in fruits and vegetables other than dietary fiber. Meals were prepared in one batch. The average calorie intake and the proportion of macronutrients were also maintained similar.
Intervention code [1] 269386 0
Prevention
Intervention code [2] 269421 0
Treatment: Other
Comparator / control treatment
Subjects participated phase 1 and phase 2 interventions which was apart by 2 weeks. Comparisions were made bewtween these two phases and each phase served as control for the other phase. There was no other control group or treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279646 0
C-reactive protein (CRP) was used as a primary outcome becasue this often represent chronic inflammatory responses related to obesity.
Timepoint [1] 279646 0
1)Baseline before starting low vegetables and fruits(VF) diet intervention

2) At 2 weeks after low VF diet intervention

3) Baseline before starting low VF diet intervention

4) At 2 weeks after high VF diet intervention
Secondary outcome [1] 294115 0
Lymphocyte DNA damage (tail moment, tail length)
Timepoint [1] 294115 0
1) Baseline before starting low VF diet intervention

2) At 2 weeks after low VF diet intervention

3) Baseline before starting low VF diet intervention

4) At 2 weeks after high VF diet intervention

Eligibility
Key inclusion criteria
Healthy premenopausal women with BMI>23
Minimum age
19 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoker
use of medication or multivitamin supplements
regular alcohol drinker (equal to or greater than 2 times/week)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Study subjects participated in both dietary intervetions in sequence of low-VF diet and high-VF diet
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3843 0
Korea, Republic Of
State/province [1] 3843 0
Seoul

Funding & Sponsors
Funding source category [1] 269872 0
Charities/Societies/Foundations
Name [1] 269872 0
National Research Foundation of Korea
Country [1] 269872 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Mi-Kyung Sung
Address
100 Chungpa-Ro 47-Gil
Yongsan-gu
Seoul, 140-742
Country
Korea, Republic Of
Secondary sponsor category [1] 268892 0
None
Name [1] 268892 0
Address [1] 268892 0
Country [1] 268892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271841 0
Human Research Ethics Committee of Sookmyung Women's University
Ethics committee address [1] 271841 0
100 Chungpa-Ro 47-Gil
Yongsan-gu
Seoul 140-742
Ethics committee country [1] 271841 0
Korea, Republic Of
Date submitted for ethics approval [1] 271841 0
01/04/2007
Approval date [1] 271841 0
17/05/2007
Ethics approval number [1] 271841 0
SM-IRB-07-0516

Summary
Brief summary
The purpose of this study is to determine the effects of high vegetable-fruit (high-VF) and low vegetable-fruit (low-VF) diet on various inflammation and oxidative stress biomarkers in overweight otherwise healthy subjects. High-VF diet intervention is consisted of 12 servings of fruits and vegetables/day for 2 weeks and low-VF diet intervention is consisted of 2 servings/day of fruits and vegetables for 2 weeks. Study results will provide information on the efficacy of additional fruit and vegetable supply in overweight subjects to change biomarkers are related to metabolic disturbances and possible complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33157 0
Address 33157 0
Country 33157 0
Phone 33157 0
Fax 33157 0
Email 33157 0
Contact person for public queries
Name 16404 0
Mi-Kyung Sung
Address 16404 0
100 Chungpa-Ro 47-Gil
Yongsan-gu
Seoul, 140-742
Country 16404 0
Korea, Republic Of
Phone 16404 0
+82-2-710-9395
Fax 16404 0
+82-2-710-9453
Email 16404 0
[email protected]
Contact person for scientific queries
Name 7332 0
Mi-Kyung Sung
Address 7332 0
100 Chungpa-Ro 47-Gil
Yongsan-gu
Seoul, 140-742
Country 7332 0
Korea, Republic Of
Phone 7332 0
+82-2-710-9395
Fax 7332 0
+82-2-710-9453
Email 7332 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.