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

NCT ID: NCT04737044

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-07-01

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.

Conditions

Gene Expression; Cardiometabolic Risk; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Study 1: Normal sugar

Control group will be required to continue consuming normal sugar intake for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Study 1: MRBS

Intervention Type: OTHER

MRBS as added sugar based on their habitual diet

Study 2: Normal sugar intake

\- The control group will have no intervention and will continue with their normal daily intake for six months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Study 2: White sugar & education module

Intervention Type: OTHER

White sugar for daily usage (\<10% daily energy intake)

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.

Group Type: EXPERIMENTAL

Study 2: MRBS & education module

Intervention Type: OTHER

MRBS for daily usage (\<10% daily energy intake)

Interventions

Study 1: MRBS

MRBS as added sugar based on their habitual diet

Intervention Type: OTHER

Study 2: White sugar & education module

White sugar for daily usage (\<10% daily energy intake)

Intervention Type: OTHER

Study 2: MRBS & education module

MRBS for daily usage (\<10% daily energy intake)

Intervention Type: OTHER

Other Intervention Names

Food-based and gene expression; Food-based and nutrition education study; Food-based and nutrition education study

Eligibility 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).

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Sugars Refinery Sdn Bhd, Malaysia

UNKNOWN

Sponsor Role: collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Barakatun Nisak Bt Mohd Yusof

Associate Professor Dr Barakatun Nisak Mohd Yusof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 35623864 (View on PubMed)

Other Identifiers

MySugarStudy

Identifier Type: -

Identifier Source: org_study_id