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IRCT20220317054316N3 IRCT 2022-07-31 Universiti Teknologi MARA The effect of "Afiyah" on body composition, metabolic parameters and gut microbiome of healthy adults: A double-blind, randomized controlled trial AF (Afiyah) The effect of honey plus Habbatus sauda (Nigella sativa) supplementation (Afiyah) on body composition, metabolic parameters and gut microbiome of healthy adults: A double-blind, randomized controlled trial 2022-08-23 anticipated 70 Complete https://irct.ir/trial/64753 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: no, Randomization description: The participants will be randomized into intervention and control groups using stratified permuted two by two blocks. The stratification will be on gender to obtain an equal number of gender in both groups. The third-party will assign the random allocation sequence to the participants. The concealment of allocation sequence will be conducted using random.org, Blinding description: Double blinding will be applied in this study. The investigator, participants evaluators, monitors and data analysts will be blinded. Only the manufacturer (third party) will have information on the type of treatment received by participants (whether intervention and placebo). The third party will be providing the gummies (AF and placebo). The placebo gummies will be made to resemble the AF gummies in appearance and colour. 1 Healthy adult. Intervention 1: Intervention group: The participants will be given oral supplementation with AF gummy 1 tablet (10mg) daily for 12 weeks. They will receive dietary advice from dietician on standard diet recall and to conform to 150 minutes of physical activity per week to standardize their physical activity level. Intervention 2: Control group: The participants will be given oral placebo gummy 1 tablet (10 mg) daily for 12 weeks. They will receive dietary advice from dietician on standard diet recall and to conform to 150 minutes of physical activity per week to standardize their physical activity level. Yes - There is a plan to make this available What will be shared: "Affiyah" data will be kept for the use of research only When: data will be available when the data collection finish and will be kept for 7 years To whom: only for the group members of this research Conditions: for research only Where to obtain: from the Principal Investigator How to obtain: An official letter will be needed and the reason(s) for the request Comments: No
public Nor Ashikin Bt Mohamed Noor Khan
Jalan Hospital
Sungai Buloh Malaysia 47000 +60 12-320 0348 noras011@uitm.edu.my Universiti Teknologi MARA scientific Nor Ashikin Mohamed Noor Khan
Jalan Hospital
Sungai Buloh Malaysia 47000 +60 12-320 0348 noras011@uitm.edu.my Universiti Teknologi MARA Malaysia Men and women 25 to 45 years old available to participate in the study for 12 weeks. 25 years 45 years Both Co-morbidities (known diabetes, pre-diabetes (impaired fasting glucose), hypertension, cardiovascular conditions (ischemic heart disease, peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, morbid obesity) Hypothyroidism Renal disease or malignancy or on thiazide diuretics, beta-blockers or corticosteroids. Prior hospital admission for severe illness in the past three months. Pregnant or breastfeeding in the past 12 months. Mental health issues. Smokers On other regular dietary oral supplements or medications containing antioxidants and caffeine. Treatment - Other Treatment - Other Intervention group: The participants will be given oral supplementation with AF gummy 1 tablet (10mg) daily for 12 weeks. They will receive dietary advice from dietician on standard diet recall and to conform to 150 minutes of physical activity per week to standardize their physical activity level. Control group: The participants will be given oral placebo gummy 1 tablet (10 mg) daily for 12 weeks. They will receive dietary advice from dietician on standard diet recall and to conform to 150 minutes of physical activity per week to standardize their physical activity level. To measure the effects of AF on plasma glucose, HbA1c and insulin levels, lipid profile, liver and kidney functions of healthy adults. Timepoint: baseline, after 6-week, after 12-weeks. Method of measurement: blood. To measure the effects of AF on resting blood pressure, body weight, fat percentage and waist to hip ratio in healthy adults. Timepoint: baseline, after 6-weeks, after 12- weeks. Method of measurement: anthropometric measurement. To assess the effect of AF on cognitive function in healthy adults,. Timepoint: baseline, after 6-weeks, after 12-weeks. Method of measurement: mini mental state examination. To observe the effect of AF on an oxidative stress marker (Malondialdehyde), antioxidative enzymes (Superoxide dismutase and catalase), as well as pro-inflammatory cytokines (IL-6 and IL-1β) in healthy adults. Timepoint: baseline, after 12-weeks. Method of measurement: serum blood. To measure the effects of AF on lung volume and capacity in healthy adults. Timepoint: baseline, after 6-weeks, after 12-weeks. Method of measurement: spirometry. To observe the effect of AF on an oxidative enzymes in healthy adults. Timepoint: Baseline, 6-week and after 12-week. Method of measurement: serum blood. To observe the effect of AF on diet (24 hours recall) in healthy adults. Timepoint: baseline, 6- week and after 12-week. Method of measurement: ButriPro assessment on 24 hour diet recall. To observe the effect of AF on IL-6 and IL-1beta in healthy adults. Timepoint: after 12-week. Method of measurement: serum blood. To profile the composition of the gut microbiome following a 12-week AF supplementation in healthy adults using 16s metagenomics sequencing. Timepoint: after 12-weeks. Method of measurement: feces. To identify key bacterial genera that can be potentially involved in mediating effect of AF on biochemistry and clinical parameter in healthy adults. Timepoint: after 12-week. Method of measurement: serum blood. Universiti Teknologi MARA Approved 2022-07-27 Research Ethic Committee, Universiti Teknologi MARA Research Management Centre, Universiti Teknologi MARA Shah Alam Petaling Malaysia