Clinical trial NCT04737044: Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gene Expression
Cardiometabolic Risk
Metabolic Syndrome
Keywords: Antioxidant sugar
Gene Expression
Cardio metabolic risks
Education tool
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Central Sugars Refinery Sdn Bhd, Malaysia
First posted: 2021-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study 1: Gene expression of inflammation biomarkers (interleukin-6)
timeFrame: 8 weeks
measure: Study 1: Gene expression of inflammation biomarkers (TNF-α)
timeFrame: 8 weeks
measure: Study 1: Gene expression of inflammation biomarkers (CPR)
timeFrame: 8 weeks
measure: Study 1: Gene expression of oxidative stress biomarkers (MDA)
timeFrame: 8 weeks
measure: Study 1: Gene expression of oxidative stress biomarkers (SOD)
timeFrame: 8 weeks
measure: Study 1: Gene expression of oxidative stress biomarkers (CAT)
timeFrame: 8 weeks
measure: Study 2: Change from baseline in sugar consumption
timeFrame: 3 months
measure: Study 2: Change from baseline in sugar consumption
timeFrame: 6 months
Secondary outcomes:
measure: Study 1: Inflammation biomarkers (interleukin-6)
timeFrame: 8 weeks
measure: Study 1: Inflammation biomarkers (TNF-α)
timeFrame: 8 weeks
measure: Study 1: Inflammation biomarkers (CPR)
timeFrame: 8 weeks
measure: Study 1: Oxidative stress biomarkers (MDA)
timeFrame: 8 weeks
measure: Study 1: Oxidative stress biomarkers (SOD)
timeFrame: 8 weeks
measure: Study 1: Oxidative stress biomarkers (CAT)
timeFrame: 8 weeks
measure: Study 1: TAC
timeFrame: 8 weeks
measure: Study 1: Blood pressure
timeFrame: 8 weeks
measure: Study 1: Lipid profile
timeFrame: 8 weeks
measure: Study 1: Glucose profile
timeFrame: 8 weeks
measure: Study 1: Anthropometric measurements (height)
timeFrame: 8 weeks
measure: Study 1: Anthropometric measurements (weight)
timeFrame: 8 weeks
measure: Study 1: Anthropometric measurements (waist circumference)
timeFrame: 8 weeks
measure: Study 1: Anthropometric measurements (hip circumference)
timeFrame: 8 weeks
measure: Study 1: Body mass index
timeFrame: 8 weeks
measure: Study 1: Waist hip ratio
timeFrame: 8 weeks
measure: Study 1: Change from baseline in sugar consumption at 8th weeks
timeFrame: 8 weeks
measure: Study 1: Change from baseline in physical activity level at 8th weeks
timeFrame: 8 weeks
measure: Study 1: Change from baseline in intensity of physical activity at 8th weeks
timeFrame: 8 weeks
measure: Study 2: Change from baseline in anthropometric measurements (height)
timeFrame: 3 months
measure: Study 2: Change from baseline in anthropometric measurements (weight)
timeFrame: 3 months
measure: Study 2: Change from baseline in anthropometric measurements (waist circumference)
timeFrame: 3 months
measure: Study 2: Change from baseline in anthropometric measurements (hip circumference)
timeFrame: 3 months
measure: Study 2: Change from baseline in body mass index
timeFrame: 3 months
measure: Study 2: Change from baseline in waist hip ratio
timeFrame: 3 months
measure: Study 2: Change from baseline in blood pressure
timeFrame: 3 months
measure: Study 2: Change from baseline in lipid profile
timeFrame: 3 months
measure: Study 2: Change from baseline in sugar profile
timeFrame: 3 months
measure: Study 2: Change from baseline in antioxidant activity
timeFrame: 3 months
measure: Study 2: Change from baseline in 24-hour urinary sucrose/fructose
timeFrame: 3 months
measure: Study 2: Change from baseline in knowledge level
timeFrame: 3 months
measure: Study 2: Change from baseline in health belief
timeFrame: 3 months
measure: Study 2: Change from baseline in mental health
timeFrame: 3 months
measure: Study 2: Change from baseline in physical activity level
timeFrame: 3 months
measure: Study 2: Change from baseline in intensity of physical activity
timeFrame: 3 months
measure: Study 2: Change from baseline in anthropometric measurements (weight)
timeFrame: 6 months
measure: Study 2: Change from baseline in anthropometric measurements (height)
timeFrame: 6 months
measure: Study 2: Change from baseline in anthropometric measurements (waist circumference)
timeFrame: 6 months
measure: Study 2: Change from baseline in anthropometric measurements (hip circumference)
timeFrame: 6 months
measure: Study 2: Change from baseline in body mass index
timeFrame: 6 months
measure: Study 2: Change from baseline in waist hip ratio
timeFrame: 6 months
measure: Study 2: Change from baseline in blood pressure
timeFrame: 6 months
measure: Study 2: Change from baseline in lipid profile
timeFrame: 6 months
measure: Study 2: Change from baseline in sugar profile
timeFrame: 6 months
measure: Study 2: Change from baseline in antioxidant activity
timeFrame: 6 months
measure: Study 2: Change from baseline in 24-hour urinary sucrose/fructose
timeFrame: 6 months
measure: Study 2: Change from baseline in knowledge level
timeFrame: 6 months
measure: Study 2: Change from baseline in health belief
timeFrame: 6 months
measure: Study 2: Change from baseline in mental health
timeFrame: 6 months
measure: Study 2: Change from baseline in physical activity level
timeFrame: 6 months
measure: Study 2: Change from baseline in intensity of physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
References:
citation: 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.