Cultural Meal and Postprandial Oxidative Stress

Oxidative Stress Clinical Trial

Official title:

A Randomized Crossover Trial to Compare the Changes of Postprandial Oxidative Stress After Consumption of Meals From Different Cultures in Healthy Chinese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006771
• Other study ID #: 461813
• Secondary ID: 461813
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: January 6, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of POS differ with meals from different cultures. Four cultural meals are chosen, namely Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and Northern Chinese population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Apparently healthy male or female of Chinese ethnicity with BMI less than 25 kg/m2

• Aged from 18 to 45 years for female to avoid menopausal effect, and 18 to 50 years for male (inclusive)

• Normal glucose tolerance as assessed by fasting HbA1c of <6% at the screening

• Willing to give consent and follow the study procedures

Exclusion Criteria:

• Lifestyle factors that affect POS as shown by the literature including

• Current smoker

• Physically active as defined by three days or more of 30 minutes [accumulated over the course of a day] moderate to vigorous activity weekly in the past three months. Vigorous physical activity is described as causing heavy sweating or a large increase in breathing or heart rate, and moderate as causing light sweating or a slight to moderate increase in breathing or heart rate.

• Regular or current use of vitamin or antioxidant supplements

• Pregnant or lactating

• Concurrent participation in any clinical trial or dietary intervention program

• Adherence to a special diet, allergies or aversions to foods on the study meals

• Use of medications that could affect study outcomes

• With diabetes, hypertension, renal, liver or thyroid dysfunction, any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Other:
• Southern Chinese meal
White rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil
• Northern Chinese meal
Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil
• American meal
Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces)
• South Indian meal
Basmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon)

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal		pre-meal (0 hour), 2, 4, 6 hours post-meal	No
Secondary	Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal		pre-meal (0 hour), 2, 4, 6 hours post-meal	No