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The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults

Primary Purpose

Obesity, Central Obesity

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Low GI diet
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Chinese adult, obesity, low glycemic index diet, cardiometabolic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • District Councilor Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low GI diet group

Control group

Arm Description

The components of the Low GI diet group include: (1) A one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. (2) An informational booklet will be given out during the education session. (3) 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.

The components of the control group include: (1) Pamphlets from the Department of Health about obesity and a balanced diet based on the food pyramid will be distributed. (2)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.

Outcomes

Primary Outcome Measures

Body mass index (BMI)
within- and between-participant changes in BMI, BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from body mass in kilograms(kg) and body height in metres(m).The body mass and body height will be assessed using an electronic scale and a wall-mounted stadiometer, respectively.

Secondary Outcome Measures

waist circumference
within- and between-participant changes in waist circumference. Waist circumference will be measured by using the midway point between the top of the hip bone and base of the ribs as a landmark in centimeters(cm) on bare skin at the end of a normal expiration, with arms relaxed at the sides
body fat
within- and between-participant changes in body fat. Body fat percentage (%) and different body compositions (visceral fat, subcutaneous whole body, subcutaneous trunk, subcutaneous arms, subcutaneous legs) will be assessed by body composition analyser based on the principles of bioelectrical impedance
blood pressure
within- and between-participant changes in blood pressure. Blood pressure is measured in terms of the systolic pressure over diastolic pressure and is measured in millimeters of mercury (mmHg)
fasting plasma glucose
within- and between-participant changes in fasting plasma glucose. Fasting plasma glucose will be drawn by venipuncture after an eight-hour overnight. fast for laboratory testing. Fasting plasma glucose is measured in millimoles per liter (mmol/L)
Hemoglobin A1c (HbA1c)
within- and between-participant changes in HbA1c. HbA1c will be drawn by venipuncture after an eight-hour overnight fast for laboratory testing. HbA1c will be measured in percentage (%)
Total cholesterol (TC)
within- and between-participant changes in Total cholesterol (TC). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
HDL-cholesterol (HDL-C)
within- and between-participant changes in HDL-cholesterol (HDL-C). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
LDL-cholesterol (LDL-C)
within- and between-participant changes in LDL-cholesterol (LDL-C) level. It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Triglycerides level (TG)
within- and between-participant changes in triglycerides level (TG). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measure in millimoles per liter (mmol/L)
dietary glycemic index (GI) value
within- and between-participant changes in dietary GI value. The dietary GI value for each participant will be calculated by summing the products of the percentage contribution of each individual food to daily available carbohydrate intake multiplied by the food's GI value.
dietary glycemic load
within- and between-participant changes in dietary glycemic load. The dietary GL will be calculated by multiplying the dietary GI by the total amount of daily available carbohydrate intake. Dietary will be measured as g per 1000 kcal
calories
within- and between-participant changes in calories [kcal] intake
carbohydrates
within- and between-participant changes in carbohydrates[g] intake
fat
within- and between-participant changes in fat [g] intake
proteins
within- and between-participant changes in proteins[g] intake
fiber
within- and between-participant changes in fiber[g] intake
the sense of fullness as dietary satiety
within- and between-participant changes in the sense of fullness as dietary satiety. The sense of satiety with diet will be assessed by a visual analogue scale (VAS) consisting of a 100mm long line with the left anchor representing "very hungry" and the right anchor representing "very full." The satiety premeal, postmeal and 2 hours postmeal will be measured.

Full Information

First Posted
October 30, 2019
Last Updated
March 12, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04152213
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Central Obesity
Keywords
Chinese adult, obesity, low glycemic index diet, cardiometabolic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, two-arm randomized-controlled trial
Masking
Outcomes Assessor
Masking Description
Research assistants who have no knowledge about group allocation and study's objectives, will collected the post-intervention data.
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low GI diet group
Arm Type
Experimental
Arm Description
The components of the Low GI diet group include: (1) A one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. (2) An informational booklet will be given out during the education session. (3) 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The components of the control group include: (1) Pamphlets from the Department of Health about obesity and a balanced diet based on the food pyramid will be distributed. (2)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.
Intervention Type
Behavioral
Intervention Name(s)
Low GI diet
Intervention Description
This educational session will cover information on obesity, complications of obesity, the benefit of weight loss, the glycemic index and its associated low GI diet, a food-exchange table including high- to low-GI foods, and self-decision in food choices. The dietary advice will be based on the standard food pyramid for the conventional Chinese diet as promoted by the Hong Kong Department of Health, with an emphasis on the selection of low-GI products. Practical tips will be given such as the selection of low-GI rice and rice products, the impact of cooking methods (including cooking time, cooking conditions, and cooking liquid volume) on rice GI, intervention to reduce the GI of rice, and listing low-GI food options and meal plans.
Primary Outcome Measure Information:
Title
Body mass index (BMI)
Description
within- and between-participant changes in BMI, BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from body mass in kilograms(kg) and body height in metres(m).The body mass and body height will be assessed using an electronic scale and a wall-mounted stadiometer, respectively.
Time Frame
baseline and 12th week
Secondary Outcome Measure Information:
Title
waist circumference
Description
within- and between-participant changes in waist circumference. Waist circumference will be measured by using the midway point between the top of the hip bone and base of the ribs as a landmark in centimeters(cm) on bare skin at the end of a normal expiration, with arms relaxed at the sides
Time Frame
baseline and 12th week
Title
body fat
Description
within- and between-participant changes in body fat. Body fat percentage (%) and different body compositions (visceral fat, subcutaneous whole body, subcutaneous trunk, subcutaneous arms, subcutaneous legs) will be assessed by body composition analyser based on the principles of bioelectrical impedance
Time Frame
baseline and 12th week
Title
blood pressure
Description
within- and between-participant changes in blood pressure. Blood pressure is measured in terms of the systolic pressure over diastolic pressure and is measured in millimeters of mercury (mmHg)
Time Frame
baseline and 12th week
Title
fasting plasma glucose
Description
within- and between-participant changes in fasting plasma glucose. Fasting plasma glucose will be drawn by venipuncture after an eight-hour overnight. fast for laboratory testing. Fasting plasma glucose is measured in millimoles per liter (mmol/L)
Time Frame
baseline and 12th week
Title
Hemoglobin A1c (HbA1c)
Description
within- and between-participant changes in HbA1c. HbA1c will be drawn by venipuncture after an eight-hour overnight fast for laboratory testing. HbA1c will be measured in percentage (%)
Time Frame
baseline and 12th week
Title
Total cholesterol (TC)
Description
within- and between-participant changes in Total cholesterol (TC). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Time Frame
baseline and 12th week
Title
HDL-cholesterol (HDL-C)
Description
within- and between-participant changes in HDL-cholesterol (HDL-C). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Time Frame
baseline and 12th week
Title
LDL-cholesterol (LDL-C)
Description
within- and between-participant changes in LDL-cholesterol (LDL-C) level. It will be drawn by venipuncture after an eight-hour overnight fast. It will be measured in millimoles per liter (mmol/L)
Time Frame
baseline and 12th week
Title
Triglycerides level (TG)
Description
within- and between-participant changes in triglycerides level (TG). It will be drawn by venipuncture after an eight-hour overnight fast. It will be measure in millimoles per liter (mmol/L)
Time Frame
baseline and 12th week
Title
dietary glycemic index (GI) value
Description
within- and between-participant changes in dietary GI value. The dietary GI value for each participant will be calculated by summing the products of the percentage contribution of each individual food to daily available carbohydrate intake multiplied by the food's GI value.
Time Frame
baseline and 12th week
Title
dietary glycemic load
Description
within- and between-participant changes in dietary glycemic load. The dietary GL will be calculated by multiplying the dietary GI by the total amount of daily available carbohydrate intake. Dietary will be measured as g per 1000 kcal
Time Frame
baseline and 12th week
Title
calories
Description
within- and between-participant changes in calories [kcal] intake
Time Frame
baseline and 12th week
Title
carbohydrates
Description
within- and between-participant changes in carbohydrates[g] intake
Time Frame
baseline and 12th week
Title
fat
Description
within- and between-participant changes in fat [g] intake
Time Frame
baseline and 12th week
Title
proteins
Description
within- and between-participant changes in proteins[g] intake
Time Frame
baseline and 12th week
Title
fiber
Description
within- and between-participant changes in fiber[g] intake
Time Frame
baseline and 12th week
Title
the sense of fullness as dietary satiety
Description
within- and between-participant changes in the sense of fullness as dietary satiety. The sense of satiety with diet will be assessed by a visual analogue scale (VAS) consisting of a 100mm long line with the left anchor representing "very hungry" and the right anchor representing "very full." The satiety premeal, postmeal and 2 hours postmeal will be measured.
Time Frame
baseline and 12th week
Other Pre-specified Outcome Measures:
Title
International Physical Activity Questionnaire (IPAQ-C)
Description
9 items among four domains on the health-related physical activity. A summary score of metabolic equivalent task/min per week and a categorical score of physical activity (low, moderate and high) will be used to determine the physical activity level of the participants. Physical activity are categories three level: low, moderate and high
Time Frame
baseline and 12th week
Title
self-administer questionnaire
Description
process evaluation with open-ended questions to identify the acceptability, perceived barriers and experience of low GI diet from participants' perspective
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >25.0 kg/m2; Waist circumference > 90 cm for men and > 80 cm for women; Aged eighteen years or older; Chinese ethnicity; Can be contacted by telephone; Have the ability to read and understand Chinese; and Can provide informed consent. Exclusion Criteria: Concurrently participating in any other clinical trials; Concurrently participating in weight control programs; Concomitant intake of weight reduction drugs; Use of calorie restricted diet or specialized diets which contraindicated with low GI diet; Have gastrointestinal problems that would prevent them from following the prescribed diet.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sek Ying Chair
Organizational Affiliation
The Nethersole School of Nursing, The Chinese University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
District Councilor Office
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults

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