Effects of Antioxidant Sugar vs Granulated Sugar on Metabolic Outcomes in Healthy and Cardio Metabolic Subjects

Metabolic Syndrome Clinical Trial

— MSS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04737044
• Other study ID #: MySugarStudy
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2023
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Gene Expression
• Metabolic Syndrome

Intervention

Other:
• Study 1: MRBS
MRBS as added sugar based on their habitual diet
• Study 2: White sugar & education module
White sugar for daily usage (<10% daily energy intake)
• Study 2: MRBS & education module
MRBS for daily usage (<10% daily energy intake)

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Central Sugars Refinery Sdn Bhd, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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