Cultural Meal and Postprandial Oxidative Stress

NCT02006771 | Completed DMC

• 1 other identifier: 461813
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress

Keywords

Meal; Postprandial oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change of plasma allantoin from 0 (pre-meal) to 6 hours post-meal

  pre-meal (0 hour), 2, 4, 6 hours post-meal

Secondary Outcomes (1)

• Change of urine F2-isoprostanes from 0 (pre-meal) to 6 hours post-meal

  pre-meal (0 hour), 2, 4, 6 hours post-meal

Study Arms (4)

Southern Chinese meal

EXPERIMENTAL

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

Northern Chinese meal

EXPERIMENTAL

Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil

Other: Northern Chinese meal

American meal

EXPERIMENTAL

Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil plus Coca-cola classic (21 fluid ounces)

Other: American meal

South Indian meal

EXPERIMENTAL

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

Interventions

Southern Chinese meal OTHER

White rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil

Southern Chinese meal

Northern Chinese meal OTHER

Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil

Northern Chinese meal

American meal OTHER

Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces)

American meal

South Indian meal OTHER

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)

South Indian meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

Location

Study Officials

• Ruth Chan, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant professor

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

CN (1)