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Completed

NCT Number: NCT02006771

Cultural Meal and Postprandial Oxidative Stress

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Northern Chinese meal

Other

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

American meal

Other

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

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)

Primary outcomes

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2013
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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