Clinical trial NCT04152213: The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults
Official title: The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Central Obesity
Keywords: Chinese adult
obesity
low glycemic index diet
cardiometabolic
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, two-arm randomized-controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.

Detailed description: 29.9% of persons aged 15-84 in Hong Kong are obese. Obesity poses significant detrimental consequences for one's health. Obese patients have an increased risk of mortality when compared with people with normal BMI. Obesity results in arterial hypertension, hyperlipidaemia, heart disease and type 2 diabetes. Low GI diets have been investigated for their impact on weight control. Evidence showed that low GI diets were effective in lowering body mass index. However, the evidence was usually generated from Western populations, thus excluding the influence of Chinese culture on diet.The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.

A prospective, two-arm randomized-controlled trial will be conducted to examine the effect of a low GI diet education program on cardiometabolic outcomes in Chinese adults with obesity. The intervention group will receive a low GI diet education, including a one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. An informational booklet will be given out during the education session.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. While the control group will receive an education pamphlets on obesity and balanced diet.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets.

At baseline, demographic and clinical data, including BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, International Physical Activity Questionnaire (IPAQ-C), and the sense of fullness will be collected.

On the 12th week, data about the BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, IPAQ-C, and the sense of fullness and a questionnaire on the evaluation process will be collected.

Eligibility criteria: Inclusion Criteria:

1. BMI \>25.0 kg/m2;
2. Waist circumference \> 90 cm for men and \> 80 cm for women;
3. Aged eighteen years or older;
4. Chinese ethnicity;
5. Can be contacted by telephone;
6. Have the ability to read and understand Chinese; and
7. Can provide informed consent.

Exclusion Criteria:

1. Concurrently participating in any other clinical trials;
2. Concurrently participating in weight control programs;
3. Concomitant intake of weight reduction drugs;
4. Use of calorie restricted diet or specialized diets which contraindicated with low GI diet;
5. Have gastrointestinal problems that would prevent them from following the prescribed diet.

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: baseline and 12th week
Secondary outcomes:
measure: waist circumference
timeFrame: baseline and 12th week
measure: body fat
timeFrame: baseline and 12th week
measure: blood pressure
timeFrame: baseline and 12th week
measure: fasting plasma glucose
timeFrame: baseline and 12th week
measure: Hemoglobin A1c (HbA1c)
timeFrame: baseline and 12th week
measure: Total cholesterol (TC)
timeFrame: baseline and 12th week
measure: HDL-cholesterol (HDL-C)
timeFrame: baseline and 12th week
measure: LDL-cholesterol (LDL-C)
timeFrame: baseline and 12th week
measure: Triglycerides level (TG)
timeFrame: baseline and 12th week
measure: dietary glycemic index (GI) value
timeFrame: baseline and 12th week
measure: dietary glycemic load
timeFrame: baseline and 12th week
measure: calories
timeFrame: baseline and 12th week
measure: carbohydrates
timeFrame: baseline and 12th week
measure: fat
timeFrame: baseline and 12th week
measure: proteins
timeFrame: baseline and 12th week
measure: fiber
timeFrame: baseline and 12th week
measure: the sense of fullness as dietary satiety
timeFrame: baseline and 12th week
Other outcomes:
measure: International Physical Activity Questionnaire (IPAQ-C)
timeFrame: baseline and 12th week
measure: self-administer questionnaire
timeFrame: 12th week
Locations:
city: Hong Kong
country: Hong Kong
facility: District Councilor Office
Study officials:
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Sek Ying Chair
role: STUDY_DIRECTOR
References: