Cultural Meal and Postprandial Oxidative Stress

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

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Other: Southern Chinese meal; Other: Northern Chinese meal; Other: American meal; Other: South Indian meal

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: Northern Chinese meal; Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil	Other: Northern Chinese meal; Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil
Experimental: American meal; Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil plus Coca-cola classic (21 fluid ounces)	Other: American meal; Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces)
Experimental: 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)	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal	pre-meal (0 hour), 2, 4, 6 hours post-meal

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal	pre-meal (0 hour), 2, 4, 6 hours post-meal

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Ruth Chan, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 28, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Meal; Postprandial oxidative stress
• Other Study ID Numbers: 461813 (Other Grant/Funding Number: GRF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No