Gene ExpressionMSSNCT04737044
Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects
A study testing Study 1: MRBS, Study 2: White sugar & education module and Study 2: MRBS & education module in people with Gene Expression and Cardiometabolic Risk, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Expression, Cardiometabolic Risk, Metabolic Syndrome
- What is being tested?
- Study 1: MRBS, Study 2: White sugar & education module and Study 2: MRBS & education module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Malaysian, aged ≥18-59 years old
- Able to read, write and communicate well either in Malay or English
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
Read the 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.
- Conditions
- Gene Expression, Cardiometabolic Risk, Metabolic Syndrome
- Being tested
- Study 1: MRBS, Study 2: White sugar & education module, Study 2: MRBS & education module
- Keywords
- Antioxidant sugar, Gene Expression, Cardio metabolic risks, Education tool
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 1: MRBSOther
Also called Food-based and gene expression
MRBS as added sugar based on their habitual diet
Study 2: White sugar & education moduleOther
Also called Food-based and nutrition education study
White sugar for daily usage (<10% daily energy intake)
Study 2: MRBS & education moduleOther
Also called Food-based and nutrition education study
MRBS for daily usage (<10% daily energy intake)
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Normal sugar | No intervention | Control group will be required to continue consuming normal sugar intake for 8 weeks. |
| Study 1:Minimally refined brown sugar (MRBS) | Experimental | Intervention group will be required to consume MRBS as added sugar based on their habitual diet for 8 weeks intervention. Receives: Other: Study 1: MRBS |
| Study 2: Normal sugar intake | No intervention | - The control group will have no intervention and will continue with their normal daily intake for six months. |
| Study 2: White sugar | Experimental | * 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. Receives: Other: Study 2: White sugar & education module |
| Study 2: MRBS | Experimental | * 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. Receives: Other: Study 2: MRBS & education module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Gene expression of inflammation biomarkers (interleukin-6)
Change from baseline in gene expression of interleukin-6 in micrograms at 8th weeks.
Measured: 8 weeks
Study 1: Gene expression of inflammation biomarkers (TNF-α)
Change from baseline in gene expression of TNF-α in picograms per milliliter at 8th weeks.
Measured: 8 weeks
Study 1: Gene expression of inflammation biomarkers (CPR)
Change from baseline in gene expression of CPR in milligram per liter at 8th weeks.
Measured: 8 weeks
Study 1: Gene expression of oxidative stress biomarkers (MDA)
Change from baseline in gene expression of MDA in millimolar at 8th weeks.
Measured: 8 weeks
Study 1: Gene expression of oxidative stress biomarkers (SOD)
Change from baseline in gene expression of SOD in Units per milliliter at 8th weeks.
Measured: 8 weeks
Study 1: Gene expression of oxidative stress biomarkers (CAT)
Change from baseline in gene expression of CAT in nanomoles at 8th weeks.
Measured: 8 weeks
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.)].
Measured: 3 months
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.)].
Measured: 6 months
Secondary outcomes (51)
Study 1: Inflammation biomarkers (interleukin-6)
Change from baseline in interleukin-6 in micrograms at 8th weeks.
Measured: 8 weeks
Study 1: Inflammation biomarkers (TNF-α)
Change from baseline in TNF-α in picograms per milliliter at 8th weeks.
Measured: 8 weeks
Study 1: Inflammation biomarkers (CPR)
Change from baseline in CPR in milligram per liter at 8th weeks.
Measured: 8 weeks
Study 1: Oxidative stress biomarkers (MDA)
Change from baseline in MDA in millimolar at 8th weeks.
Measured: 8 weeks
Study 1: Oxidative stress biomarkers (SOD)
Change from baseline in SOD in Units per milliliter at 8th weeks.
Measured: 8 weeks
Study 1: Oxidative stress biomarkers (CAT)
Change from baseline in CAT in nanomoles at 8th weeks.
Measured: 8 weeks
Study 1: TAC
Change from baseline in TAC in millimolar at 8th weeks.
Measured: 8 weeks
Study 1: Blood pressure
Change from baseline in blood pressure in mmHg at 8th weeks.
Measured: 8 weeks
Study 1: Lipid profile
Change from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L at 8th weeks.
Measured: 8 weeks
Study 1: Glucose profile
Change from baseline in fasting glucose in mmol/L at 8th weeks.
Measured: 8 weeks
Study 1: Anthropometric measurements (height)
Change from baseline in height in meters at 8th weeks.
Measured: 8 weeks
Study 1: Anthropometric measurements (weight)
Change from baseline in weight in kilograms at 8th weeks.
Measured: 8 weeks
Study 1: Anthropometric measurements (waist circumference)
Change from baseline in waist circumference in centimeters at 8th weeks.
Measured: 8 weeks
Study 1: Anthropometric measurements (hip circumference)
Change from baseline in hip circumference in centimeters at 8th weeks.
Measured: 8 weeks
Study 1: Body mass index
Weight (kg) and height (m) will be combined to report body mass index in kg/m2.
Measured: 8 weeks
Study 1: Waist hip ratio
Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio
Measured: 8 weeks
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.)].
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Study 2: Change from baseline in anthropometric measurements (height)
Height in meters will be taken.
Measured: 3 months
Study 2: Change from baseline in anthropometric measurements (weight)
Weight in meters will be taken.
Measured: 3 months
Study 2: Change from baseline in anthropometric measurements (waist circumference)
Waist circumference in centimeters will be taken.
Measured: 3 months
Study 2: Change from baseline in anthropometric measurements (hip circumference)
Hip circumference in centimeters will be taken.
Measured: 3 months
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.
Measured: 3 months
Study 2: Change from baseline in waist hip ratio
Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.
Measured: 3 months
Study 2: Change from baseline in blood pressure
Blood pressure in mmHg will be taken.
Measured: 3 months
Study 2: Change from baseline in lipid profile
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.
Measured: 3 months
Study 2: Change from baseline in sugar profile
Fasting glucose in mmol/L will be measured.
Measured: 3 months
Study 2: Change from baseline in antioxidant activity
Antioxidant activity in mmol/L will be measured.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Study 2: Change from baseline in anthropometric measurements (weight)
Weight in meters will be taken.
Measured: 6 months
Study 2: Change from baseline in anthropometric measurements (height)
Height in meters will be taken.
Measured: 6 months
Study 2: Change from baseline in anthropometric measurements (waist circumference)
Waist circumference in centimeters will be taken.
Measured: 6 months
Study 2: Change from baseline in anthropometric measurements (hip circumference)
Hip circumference in centimeters will be taken.
Measured: 6 months
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.
Measured: 6 months
Study 2: Change from baseline in waist hip ratio
Waist (cm) and hip circumference (cm) will be combined to report waist hip ratio.
Measured: 6 months
Study 2: Change from baseline in blood pressure
Blood pressure in mmHg will be taken.
Measured: 6 months
Study 2: Change from baseline in lipid profile
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L will be measured.
Measured: 6 months
Study 2: Change from baseline in sugar profile
Fasting glucose in mmol/L will be measured.
Measured: 6 months
Study 2: Change from baseline in antioxidant activity
Antioxidant activity in mmol/L will be measured.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Why it stopped: Termination of study by the Sponsor (Central Sugars Refinery Sdn. Bhd. Malaysia)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gene ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study 1: The study will be using a two-arm single-blinded RCT with 40 subjects in each of the intervention and control groups. Study 2: The study will be using a three-arm RCT with 23 subjects in each groups (two interventions and one control groups).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Central Sugars Refinery Sdn Bhd, Malaysia
- Responsible party
- Principal investigator, Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737044
- Sponsor's protocol ID
- MySugarStudy
- Acronym
- MSS
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang WL, Mohd Yusof BN, Azlan A, Ismail IZ, Abu Zaid Z. Impacts of a nutrition education intervention in individuals with cardiometabolic risk: Protocol of a randomized controlled trial. Clin Nutr ESPEN. 2022 Jun;49:536-543. doi: 10.1016/j.clnesp.2022.03.037. Epub 2022 Mar 31.
PubMed 35623864
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04737044
- Acronym / sponsor ID
- MSS / MySugarStudy
- Conditions
- Gene Expression, Cardiometabolic Risk, Metabolic Syndrome
- Keywords
- Antioxidant sugar, Gene Expression, Cardio metabolic risks, Education tool
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study by the Sponsor (Central Sugars Refinery Sdn. Bhd. Malaysia)
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Central Sugars Refinery Sdn Bhd, Malaysia
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Study 1: The study will be using a two-arm single-blinded RCT with 40 subjects in each of the intervention and control groups. Study 2: The study will be using a three-arm RCT with 23 subjects in each groups (two interventions and one control groups).
| Arm | Type | Receives |
|---|---|---|
| Study 1: Normal sugar | No intervention | –Control group will be required to continue consuming normal sugar intake for 8 weeks. |
| Study 1:Minimally refined brown sugar (MRBS) | Experimental | Other: Study 1: MRBSIntervention group will be required to consume MRBS as added sugar based on their habitual diet for 8 weeks intervention. |
| Study 2: Normal sugar intake | No intervention | –- The control group will have no intervention and will continue with their normal daily intake for six months. |
| Study 2: White sugar | Experimental | Other: Study 2: White sugar & education module* 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. |
| Study 2: MRBS | Experimental | Other: Study 2: MRBS & education module* 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
- Malaysian, aged ≥18-59 years old
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 1: MRBSAlso: Food-based and gene expressionMRBS as added sugar based on their habitual diet | Other | Study 1:Minimally refined brown sugar (MRBS) |
| Study 2: White sugar & education moduleAlso: Food-based and nutrition education studyWhite sugar for daily usage (<10% daily energy intake) | Other | Study 2: White sugar |
| Study 2: MRBS & education moduleAlso: Food-based and nutrition education studyMRBS for daily usage (<10% daily energy intake) | Other | Study 2: MRBS |
Primary outcome
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 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 inflammation biomarkers (CPR)
Time frame: 8 weeks
Change from baseline in gene expression of CPR in milligram per liter 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 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 oxidative stress biomarkers (CAT)
Time frame: 8 weeks
Change from baseline in gene expression of CAT in nanomoles 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.)].
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.)].
51 secondary outcomes
Study 1: Inflammation biomarkers (interleukin-6)
Time frame: 8 weeks
Study 1: Inflammation biomarkers (TNF-α)
Time frame: 8 weeks
Study 1: Inflammation biomarkers (CPR)
Time frame: 8 weeks
Study 1: Oxidative stress biomarkers (MDA)
Time frame: 8 weeks
Study 1: Oxidative stress biomarkers (SOD)
Time frame: 8 weeks
Study 1: Oxidative stress biomarkers (CAT)
Time frame: 8 weeks
Study 1: TAC
Time frame: 8 weeks
Study 1: Blood pressure
Time frame: 8 weeks
Study 1: Lipid profile
Time frame: 8 weeks
Study 1: Glucose profile
Time frame: 8 weeks
Study 1: Anthropometric measurements (height)
Time frame: 8 weeks
Study 1: Anthropometric measurements (weight)
Time frame: 8 weeks
Study 1: Anthropometric measurements (waist circumference)
Time frame: 8 weeks
Study 1: Anthropometric measurements (hip circumference)
Time frame: 8 weeks
Study 1: Body mass index
Time frame: 8 weeks
Study 1: Waist hip ratio
Time frame: 8 weeks
Study 1: Change from baseline in sugar consumption at 8th weeks
Time frame: 8 weeks
Study 1: Change from baseline in physical activity level at 8th weeks
Time frame: 8 weeks
Study 1: Change from baseline in intensity of physical activity at 8th weeks
Time frame: 8 weeks
Study 2: Change from baseline in anthropometric measurements (height)
Time frame: 3 months
Study 2: Change from baseline in anthropometric measurements (weight)
Time frame: 3 months
Study 2: Change from baseline in anthropometric measurements (waist circumference)
Time frame: 3 months
Study 2: Change from baseline in anthropometric measurements (hip circumference)
Time frame: 3 months
Study 2: Change from baseline in body mass index
Time frame: 3 months
Study 2: Change from baseline in waist hip ratio
Time frame: 3 months
Study 2: Change from baseline in blood pressure
Time frame: 3 months
Study 2: Change from baseline in lipid profile
Time frame: 3 months
Study 2: Change from baseline in sugar profile
Time frame: 3 months
Study 2: Change from baseline in antioxidant activity
Time frame: 3 months
Study 2: Change from baseline in 24-hour urinary sucrose/fructose
Time frame: 3 months
Study 2: Change from baseline in knowledge level
Time frame: 3 months
Study 2: Change from baseline in health belief
Time frame: 3 months
Study 2: Change from baseline in mental health
Time frame: 3 months
Study 2: Change from baseline in physical activity level
Time frame: 3 months
Study 2: Change from baseline in intensity of physical activity
Time frame: 3 months
Study 2: Change from baseline in anthropometric measurements (weight)
Time frame: 6 months
Study 2: Change from baseline in anthropometric measurements (height)
Time frame: 6 months
Study 2: Change from baseline in anthropometric measurements (waist circumference)
Time frame: 6 months
Study 2: Change from baseline in anthropometric measurements (hip circumference)
Time frame: 6 months
Study 2: Change from baseline in body mass index
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Termination of study by the Sponsor (Central Sugars Refinery Sdn. Bhd. Malaysia)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 35623864Chiang WL, Mohd Yusof BN, Azlan A, Ismail IZ, Abu Zaid Z. Impacts of a nutrition education intervention in individuals with cardiometabolic risk: Protocol of a randomized controlled trial. Clin Nutr ESPEN. 2022 Jun;49:536-543. doi: 10.1016/j.clnesp.2022.03.037. Epub 2022 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 1: MRBS, Study 2: White sugar & education module and Study 2: MRBS & education module in people with Gene Expression and Cardiometabolic Risk, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination of study by the Sponsor (Central Sugars Refinery Sdn. Bhd. Malaysia)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: Gene expression of inflammation biomarkers (interleukin-6) (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.