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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Study 1: Gene expression of oxidative stress biomarkers (CAT)
Study Overview
Brief Summary
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
Detailed Description
Study 1:
After being informed about the study and potential risks, written informed consent will be obtained from all subjects involved in the study. Respondents will be interviewed at Nutritional Status Assessments Lab at University of Putra, Malaysia (UPM) to obtain socio-demographic data, medical status, nutritional status, lifestyle practices and daily dietary intake. This study will be conducted for a period of 8 weeks. The study design is single-blinded parallel-randomized controlled trial (n=80), with 40 subjects in each group (one intervention and one control group). The participants will be selected based on the inclusion and exclusion criteria.
Study 2:
After being informed about the study and potential risks, written informed consent will be obtained from all subjects involved in the study prior to commencing the study. Respondents will be screened at Nutritional Status Assessments Lab at UPM for mental health status, daily sugar intake, cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol) where blood pressure and blood sample will be taken by the phlebotomist. Female candidates will be screened for pregnancy or breast feeding. Those who meet the inclusion/exclusion criteria will be selected. They will be informed via communication application whether they are eligible for the study. This study will be conducted for a period of 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
- •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
Arms & Interventions
Study 1: Normal sugar
Control group will be required to continue consuming normal sugar intake for 8 weeks.
Study 1:Minimally refined brown sugar (MRBS)
Intervention group will be required to consume MRBS as added sugar based on their habitual diet for 8 weeks intervention.
Intervention: Study 1: MRBS (Other)
Study 2: Normal sugar intake
- The control group will have no intervention and will continue with their normal daily intake for six months.
Study 2: White sugar
- Intervention group I will be advised to reduce sugar intake to no more than 10% from total energy intake.
- Intervention group I will be given white sugar for daily usage.
- Participants in this group will be exposed to the nutrition education module (45 minutes per session, once a week) for six months, attend lecture classes and communicate with health educators through communication applications.
- For the first three months, one-to-one diet counseling will be conducted.
- Participants' intake of free sugar, as well as other nutrients (carbohydrate, protein, fats, fibre and others) will be closely monitored to ensure compliance to dietary recommendations.
Intervention: Study 2: White sugar & education module (Other)
Study 2: MRBS
- Intervention group II will be advised to reduce sugar intake to no more than 10% from total energy intake.
- Intervention group II will be given MRBS for daily usage.
- Participants in this group will be exposed to the nutrition education module (45 minutes per session, once a week) for six months, attend lecture classes and communicate with health educators through communication applications.
- For the first three months, one-to-one diet counseling will be conducted.
- Participants' intake of free sugar, as well as other nutrients (carbohydrate, protein, fats, fibre and others) will be closely monitored to ensure compliance to dietary recommendations.
Intervention: Study 2: MRBS & education module (Other)
Outcomes
Primary Outcomes
Study 1: Gene expression of oxidative stress biomarkers (CAT)
Time Frame: 8 weeks
Change from baseline in gene expression of CAT in nanomoles at 8th weeks.
Study 1: Gene expression of inflammation biomarkers (TNF-α)
Time Frame: 8 weeks
Change from baseline in gene expression of TNF-α in picograms per milliliter at 8th weeks.
Study 1: Gene expression of oxidative stress biomarkers (SOD)
Time Frame: 8 weeks
Change from baseline in gene expression of SOD in Units per milliliter at 8th weeks.
Study 1: Gene expression of inflammation biomarkers (interleukin-6)
Time Frame: 8 weeks
Change from baseline in gene expression of interleukin-6 in micrograms at 8th weeks.
Study 1: Gene expression of oxidative stress biomarkers (MDA)
Time Frame: 8 weeks
Change from baseline in gene expression of MDA in millimolar at 8th weeks.
Study 2: Change from baseline in sugar consumption
Time Frame: 6 months
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 \[\>47g (9 tsps.)\].
Study 1: Gene expression of inflammation biomarkers (CPR)
Time Frame: 8 weeks
Change from baseline in gene expression of CPR in milligram per liter at 8th weeks.
Study 2: Change from baseline in sugar consumption
Time Frame: 3 months
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 \[\>47g (9 tsps.)\].
Secondary Outcomes
- Study 1: Glucose profile(8 weeks)
- Study 1: Inflammation biomarkers (TNF-α)(8 weeks)
- Study 1: Oxidative stress biomarkers (MDA)(8 weeks)
- Study 1: Oxidative stress biomarkers (SOD)(8 weeks)
- Study 1: Blood pressure(8 weeks)
- Study 1: Anthropometric measurements (waist circumference)(8 weeks)
- Study 1: Change from baseline in physical activity level at 8th weeks(8 weeks)
- Study 2: Change from baseline in anthropometric measurements (hip circumference)(6 months)
- Study 2: Change from baseline in waist hip ratio(6 months)
- Study 2: Change from baseline in lipid profile(6 months)
- Study 2: Change from baseline in antioxidant activity(6 months)
- Study 1: TAC(8 weeks)
- Study 1: Lipid profile(8 weeks)
- Study 1: Anthropometric measurements (weight)(8 weeks)
- Study 1: Anthropometric measurements (hip circumference)(8 weeks)
- Study 1: Waist hip ratio(8 weeks)
- Study 1: Inflammation biomarkers (interleukin-6)(8 weeks)
- Study 1: Inflammation biomarkers (CPR)(8 weeks)
- Study 1: Body mass index(8 weeks)
- Study 2: Change from baseline in anthropometric measurements (waist circumference)(6 months)
- Study 1: Oxidative stress biomarkers (CAT)(8 weeks)
- Study 2: Change from baseline in blood pressure(6 months)
- Study 2: Change from baseline in health belief(6 months)
- Study 2: Change from baseline in mental health(6 months)
- Study 2: Change from baseline in intensity of physical activity(6 months)
- Study 1: Anthropometric measurements (height)(8 weeks)
- Study 1: Change from baseline in intensity of physical activity at 8th weeks(8 weeks)
- Study 2: Change from baseline in anthropometric measurements (height)(6 months)
- Study 2: Change from baseline in anthropometric measurements (weight)(6 months)
- Study 2: Change from baseline in 24-hour urinary sucrose/fructose(6 months)
- Study 2: Change from baseline in physical activity level(6 months)
- Study 1: Change from baseline in sugar consumption at 8th weeks(8 weeks)
- Study 2: Change from baseline in body mass index(6 months)
- Study 2: Change from baseline in sugar profile(6 months)
- Study 2: Change from baseline in knowledge level(6 months)
- Study 2: Change from baseline in anthropometric measurements (height)(3 months)
- Study 2: Change from baseline in anthropometric measurements (weight)(3 months)
- Study 2: Change from baseline in anthropometric measurements (waist circumference)(3 months)
- Study 2: Change from baseline in anthropometric measurements (hip circumference)(3 months)
- Study 2: Change from baseline in body mass index(3 months)
- Study 2: Change from baseline in waist hip ratio(3 months)
- Study 2: Change from baseline in blood pressure(3 months)
- Study 2: Change from baseline in lipid profile(3 months)
- Study 2: Change from baseline in sugar profile(3 months)
- Study 2: Change from baseline in antioxidant activity(3 months)
- Study 2: Change from baseline in 24-hour urinary sucrose/fructose(3 months)
- Study 2: Change from baseline in knowledge level(3 months)
- Study 2: Change from baseline in health belief(3 months)
- Study 2: Change from baseline in mental health(3 months)
- Study 2: Change from baseline in physical activity level(3 months)
- Study 2: Change from baseline in intensity of physical activity(3 months)
Investigators
Barakatun Nisak Bt Mohd Yusof
Associate Professor Dr Barakatun Nisak Mohd Yusof
Universiti Putra Malaysia