Metabolic Syndrome Clinical Trial
— MSSOfficial title:
1: Effects of Antioxidant-rich Sugar as Alternative Compared to Granulated Sugar on Gene Expression and Other Metabolic Parameters in Healthy Subjects 2: Effectiveness of Education Module to Modify Sugar Consumption Among Individuals With Cardio Metabolic Risk
Verified date | February 2023 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study 1: To investigate the effects of antioxidant-rich sugar as alternative compared to granulated sugar on gene expression and other metabolic parameters in healthy subjects. The hypotheses is antioxidant-rich sugar have positive effects on reducing inflammatory cytokines, oxidative stress biomarkers and other metabolic parameters in intervention group compared to control group. Study 2: To evaluate the effectiveness of a nutrition education module in modifying sugar consumption and other CMR-related outcomes in individuals with cardiometabolic risk. The hypotheses is the nutrition education module significantly improves the sugar consumption and other CMR-related outcomes in the intervention groups compared to the control group
Status | Terminated |
Enrollment | 50 |
Est. completion date | July 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Study 1: Inclusion Criteria: - Willingness to adhere to study protocol - Healthy adults to be aged between 18 and 60 years in both genders - Being non-smoker - Body mass index (BMI) between 23 - 26.9 kg/m2 (overweight). Exclusion Criteria: - Present of any kidney, liver and/or inflammatory disease (inflammatory bowel disease, Rheumatoid arthritis and etc.), thyroid disorder, diabetes (Type 1 & Type 2), cardiovascular or metabolic disease - Individuals with impaired glucose tolerance or with fasting blood glucose level that more than 5.2 mmol/L - Pregnancy or lactation - Alcohol consumption, food allergy - Individuals who are on regular antioxidant, anti-inflammatory and /or anti-obesity drugs, receiving any glucose lowering and/or lipid lowering medications - Change in the diet and physical activity (significant weight changes during study period) - Subjects who habitually consumed beverages rich in sugar such as milo, Teh tarik more than 500 ml, (as tested with the FFQ) Study 2: Candidates will be screened for: - Cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol) - Pregnancy or breast feeding - Mental health status - Daily total sugar intake Inclusion Criteria: - Malaysian, aged =18-59 years old - Able to read, write and communicate well either in Malay or English - Attained at least formal education level (secondary school and above) - Able to use the gadgets and have access to the internet - Presence with Cardiometabolic risk defines at least any of three out of five risk factors are present and the risk factors are:waist circumference (men: =90cm, women:=80 cm); blood pressure (=130/85 mmHg); having diabetes mellitus or fasting blood sugar (=5.6mmol/L); triglyceride (=1.7 mmol/L) or high-density lipoprotein (men: <1.03 mmol/L, women: <1.3 mmol/L). - Daily free sugar intake =10% of the daily energy intake Exclusion Criteria: - Unstable mental health referring to the DASS-21 score for Depression score =5; Anxiety score =4 and Stress score =8 (Ramli, Salmiah, Nurul Ain 2009) - Uncontrolled type 2 diabetes defines as HbA1c of more than 8% or hypertriglyceridemia of > 10 mmol/L - Presence with chronic diseases-related complications such as liver disease or stage 3 chronic kidney disease - Reported abnormal thyroid stimulating hormones - On current dietary program or medication for weight loss - On cancer therapy - Having physical disabilities - Pregnancy or the desire to become pregnant in the next 3 months |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Putra Malaysia | Serdang | Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia | Central Sugars Refinery Sdn Bhd, Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study 1: Gene expression of inflammation biomarkers (interleukin-6) | Change from baseline in gene expression of interleukin-6 in micrograms at 8th weeks. | 8 weeks | |
Primary | Study 1: Gene expression of inflammation biomarkers (TNF-a) | Change from baseline in gene expression of TNF-a in picograms per milliliter at 8th weeks. | 8 weeks | |
Primary | Study 1: Gene expression of inflammation biomarkers (CPR) | Change from baseline in gene expression of CPR in milligram per liter at 8th weeks. | 8 weeks | |
Primary | Study 1: Gene expression of oxidative stress biomarkers (MDA) | Change from baseline in gene expression of MDA in millimolar at 8th weeks. | 8 weeks | |
Primary | Study 1: Gene expression of oxidative stress biomarkers (SOD) | Change from baseline in gene expression of SOD in Units per milliliter at 8th weeks. | 8 weeks | |
Primary | Study 1: Gene expression of oxidative stress biomarkers (CAT) | Change from baseline in gene expression of CAT in nanomoles at 8th weeks. | 8 weeks | |
Primary | Study 2: Change from baseline in sugar consumption | Dietary sugar intake will be determined using a 3-day food record and semi-quantitative FFQ of added sugar intake.
Total sugar (grams per day) in foods will be calculated using formula [(total sugar (grams) - natural sugar (grams)]. The total added sugar intake will be divided into four centiles i.e., 25th percentile [<10.3g (2 tsps.)], 50th percentile [10.3-23.8g (2-5 tsps.)], 75th percentile [23.8-47.0g (5-9 tsps.)] and 100th percentiles [>47g (9 tsps.)]. |
3 months | |
Primary | Study 2: Change from baseline in sugar consumption | Dietary sugar intake will be determined using a 3-day food record and semi-quantitative FFQ of added sugar intake.
Total sugar (grams per day) in foods will be calculated using formula [(total sugar (grams) - natural sugar (grams)]. The total added sugar intake will be divided into four centiles i.e., 25th percentile [<10.3g (2 tsps.)], 50th percentile [10.3-23.8g (2-5 tsps.)], 75th percentile [23.8-47.0g (5-9 tsps.)] and 100th percentiles [>47g (9 tsps.)]. |
6 months | |
Secondary | Study 1: Inflammation biomarkers (interleukin-6) | Change from baseline in interleukin-6 in micrograms at 8th weeks. | 8 weeks | |
Secondary | Study 1: Inflammation biomarkers (TNF-a) | Change from baseline in TNF-a in picograms per milliliter at 8th weeks. | 8 weeks | |
Secondary | Study 1: Inflammation biomarkers (CPR) | Change from baseline in CPR in milligram per liter at 8th weeks. | 8 weeks | |
Secondary | Study 1: Oxidative stress biomarkers (MDA) | Change from baseline in MDA in millimolar at 8th weeks. | 8 weeks | |
Secondary | Study 1: Oxidative stress biomarkers (SOD) | Change from baseline in SOD in Units per milliliter at 8th weeks. | 8 weeks | |
Secondary | Study 1: Oxidative stress biomarkers (CAT) | Change from baseline in CAT in nanomoles at 8th weeks. | 8 weeks | |
Secondary | Study 1: TAC | Change from baseline in TAC in millimolar at 8th weeks. | 8 weeks | |
Secondary | Study 1: Blood pressure | Change from baseline in blood pressure in mmHg at 8th weeks. | 8 weeks | |
Secondary | Study 1: Lipid profile | Change from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L at 8th weeks. | 8 weeks | |
Secondary | Study 1: Glucose profile | Change from baseline in fasting glucose in mmol/L at 8th weeks. | 8 weeks | |
Secondary | Study 1: Anthropometric measurements (height) | Change from baseline in height in meters at 8th weeks. | 8 weeks | |
Secondary | Study 1: Anthropometric measurements (weight) | Change from baseline in weight in kilograms at 8th weeks. | 8 weeks | |
Secondary | Study 1: Anthropometric measurements (waist circumference) | Change from baseline in waist circumference in centimeters at 8th weeks. | 8 weeks | |
Secondary | Study 1: Anthropometric measurements (hip circumference) | Change from baseline in hip circumference in centimeters at 8th weeks. | 8 weeks | |
Secondary | Study 1: Body mass index | Weight (kg) and height (m) will be combined to report body mass index in kg/m2. | 8 weeks | |
Secondary | Study 1: Waist hip ratio | Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio | 8 weeks | |
Secondary | Study 1: Change from baseline in sugar consumption at 8th weeks | Dietary sugar intake will be determined using a 3-day food record and semi-quantitative FFQ of added sugar intake.
Total sugar (grams per day) in foods will be calculated using formula [(total sugar (grams) - natural sugar (grams)]. The total added sugar intake will be divided into four centiles i.e., 25th percentile [<10.3g (2 tsps.)], 50th percentile [10.3-23.8g (2-5 tsps.)], 75th percentile [23.8-47.0g (5-9 tsps.)] and 100th percentiles [>47g (9 tsps.)]. |
8 weeks | |
Secondary | Study 1: Change from baseline in physical activity level at 8th weeks | - Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity. | 8 weeks | |
Secondary | Study 1: Change from baseline in intensity of physical activity at 8th weeks | Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity. | 8 weeks | |
Secondary | Study 2: Change from baseline in anthropometric measurements (height) | Height in meters will be taken. | 3 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (weight) | Weight in meters will be taken. | 3 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (waist circumference) | Waist circumference in centimeters will be taken. | 3 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (hip circumference) | Hip circumference in centimeters will be taken. | 3 months | |
Secondary | Study 2: Change from baseline in body mass index | Weight (kg) and height (m) will be combined to report body mass index in kg/m2. | 3 months | |
Secondary | Study 2: Change from baseline in waist hip ratio | Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio. | 3 months | |
Secondary | Study 2: Change from baseline in blood pressure | Blood pressure in mmHg will be taken. | 3 months | |
Secondary | Study 2: Change from baseline in lipid profile | Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured. | 3 months | |
Secondary | Study 2: Change from baseline in sugar profile | Fasting glucose in mmol/L will be measured. | 3 months | |
Secondary | Study 2: Change from baseline in antioxidant activity | Antioxidant activity in mmol/L will be measured. | 3 months | |
Secondary | Study 2: Change from baseline in 24-hour urinary sucrose/fructose | Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose. | 3 months | |
Secondary | Study 2: Change from baseline in knowledge level | Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage. | 3 months | |
Secondary | Study 2: Change from baseline in health belief | Health belief model construct will be determined using Health Belief Model questionnaire. Five subscales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and perceived self-efficacy will be measured and the scores will be presented in percentage. | 3 months | |
Secondary | Study 2: Change from baseline in mental health | Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7). | 3 months | |
Secondary | Study 2: Change from baseline in physical activity level | Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity. | 3 months | |
Secondary | Study 2: Change from baseline in intensity of physical activity | Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity. | 3 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (weight) | Weight in meters will be taken. | 6 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (height) | Height in meters will be taken. | 6 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (waist circumference) | Waist circumference in centimeters will be taken. | 6 months | |
Secondary | Study 2: Change from baseline in anthropometric measurements (hip circumference) | Hip circumference in centimeters will be taken. | 6 months | |
Secondary | Study 2: Change from baseline in body mass index | Weight (kg) and height (m) will be combined to report body mass index in kg/m2. | 6 months | |
Secondary | Study 2: Change from baseline in waist hip ratio | Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio. | 6 months | |
Secondary | Study 2: Change from baseline in blood pressure | Blood pressure in mmHg will be taken. | 6 months | |
Secondary | Study 2: Change from baseline in lipid profile | Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured. | 6 months | |
Secondary | Study 2: Change from baseline in sugar profile | Fasting glucose in mmol/L will be measured. | 6 months | |
Secondary | Study 2: Change from baseline in antioxidant activity | Antioxidant activity in mmol/L will be measured. | 6 months | |
Secondary | Study 2: Change from baseline in 24-hour urinary sucrose/fructose | Urinary sucrose (mg/day) and fructose (mg/day) will be combined to report 24-hour urinary sucrose/fructose. | 6 months | |
Secondary | Study 2: Change from baseline in knowledge level | Knowledge level of healthy diet and sugar will be tested using Knowledge Assessment Questionnaire. The score will be presented in percentage. | 6 months | |
Secondary | Study 2: Change from baseline in health belief | Health belief model construct will be determined using Health Belief Model questionnaire. Five subscales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and perceived self-efficacy will be measured and the scores will be presented in percentage. | 6 months | |
Secondary | Study 2: Change from baseline in mental health | Mental health status will be measured using DASS-21 questionnaire, measuring depression (normal cut-off point: 0-4), anxiety (normal cut-off point: 0-3) and stress (normal cut-off point: 0-7). | 6 months | |
Secondary | Study 2: Change from baseline in physical activity level | Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ) and results will be categorized as low, moderate and high physical activity. | 6 months | |
Secondary | Study 2: Change from baseline in intensity of physical activity | Metabolic Equivalent Task (minutes/week) will be used to assess the intensity of physical activity. | 6 months |
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