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

NCT04737044 | Terminated DMC

• 1 other identifier: MySugarStudy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gene Expression; Cardiometabolic Risk; Metabolic Syndrome

Keywords

Antioxidant sugar; Gene Expression; Cardio metabolic risks; Education tool

Outcome Measures

Primary Outcomes (8)

• 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

• 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.

  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.

  8 weeks

• Study 1: Gene expression of oxidative stress biomarkers (MDA)

  Change from baseline in gene expression of MDA in millimolar at 8th weeks.

  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.

  8 weeks

• Study 1: Gene expression of oxidative stress biomarkers (CAT)

  Change from baseline in gene expression of CAT in nanomoles at 8th weeks.

  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 \[\>47g (9 tsps.)\].

  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 \[\>47g (9 tsps.)\].

  6 months

Secondary Outcomes (51)

• Study 1: Inflammation biomarkers (interleukin-6)

  8 weeks

• Study 1: Inflammation biomarkers (TNF-α)

  8 weeks

• Study 1: Inflammation biomarkers (CPR)

  8 weeks

• Study 1: Oxidative stress biomarkers (MDA)

  8 weeks

• Study 1: Oxidative stress biomarkers (SOD)

  8 weeks

Study Arms (5)

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.

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.

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.

Other: Study 2: MRBS & education module

Interventions

Study 1: MRBS OTHER

MRBS as added sugar based on their habitual diet

Also known as: Food-based and gene expression

Study 1:Minimally refined brown sugar (MRBS)

Study 2: White sugar & education module OTHER

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

Also known as: Food-based and nutrition education study

Study 2: White sugar

Study 2: MRBS & education module OTHER

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

Also known as: Food-based and nutrition education study

Study 2: MRBS

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Malaysian, aged ≥18-59 years old
• Able to read, write and communicate well either in Malay or English

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Central Sugars Refinery Sdn Bhd, Malaysia: collaborator

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35623864 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr Barakatun Nisak Mohd Yusof

Model Details: 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).

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 3, 2021
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)