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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    149
  • sponsor
    Universiti Putra Malaysia
Updated on 26 May 2022
diabetes
cytokines
fasting
Accepts healthy volunteers

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.

Details
Condition Gene Expression, Cardiometabolic Risk, Metabolic Syndrome
Treatment Study 1: MRBS, Study 2: White sugar & education module, Study 2: MRBS & education module
Clinical Study IdentifierNCT04737044
SponsorUniversiti Putra Malaysia
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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