Protocol summary
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Study aim
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1. To measure the effects of AF on plasma glucose, HbA1c and insulin levels, lipid profile, liver and kidney functions, resting blood pressure, body weight, fat percentage and waist to hip ratio, lung volume, capacity and cognitive function
2. To observe the effect of AF on an oxidative stress marker (Malondialdehyde), antioxidative enzymes (Superoxide dismutase and catalase), pro-inflammatory cytokines (IL-6 and IL-1β)
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Design
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Randomized controlled study
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Settings and conduct
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A multiple centre, double-blind, placebo-controlled, randomised controlled trial will be conducted at several colleagues UiTM Selangor, Puncak Alam Campus
During recruitment, all participants will receive advice regarding physical activity along with assessment of their level of PA. Participants are advised to conform to 150 mins of PA per week to standardized their level of PA.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Men and women.
2. 25 to 45 years old and available to participate in the study for 12 weeks.
Exclusion criteria:
1. Co-morbidities - diabetes, pre-diabetes, hypertension, cardiovascular conditions.
2. Hypothyroidism.
3. Renal disease or malignancy or on thiazide diuretics, beta-blockers or corticosteroids.
4. Severe illness in the past three months.
5. Pregnant or breastfeeding in the past 12 months.
6. Mental health issues.
7. Smokers.
8. On other regular dietary oral supplements or medications containing antioxidants and caffeine.
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Intervention groups
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Treatment Group (AF) - Oral supplementation with AF gummy for 12 weeks.
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Main outcome variables
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plasma glucose, HbA1c and insulin levels, lipid profile, liver and kidney functions, resting blood pressure, body weight, fat percentage and waist to hip ratio cognitive function, oxidative stress marker, antioxidative enzymes, pro-inflammatory cytokines (IL-6 and IL-1β), lung volume and capacity
General information
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Reason for update
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to clarify that the investigational product tested is "Afiyah" which is a proprietary formulation of honey and habbatus sauda made into a gummy form
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Acronym
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AF (Afiyah)
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IRCT registration information
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IRCT registration number:
IRCT20220317054316N3
Registration date:
2022-07-31, 1401/05/09
Registration timing:
prospective
Last update:
2022-08-27, 1401/06/05
Update count:
1
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Registration date
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2022-07-31, 1401/05/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-23, 1401/06/01
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Expected recruitment end date
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2022-12-23, 1401/10/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of "Afiyah" on body composition, metabolic parameters and gut microbiome of healthy adults: A double-blind, randomized controlled trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men and women
25 to 45 years old
available to participate in the study for 12 weeks.
Exclusion criteria:
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.
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Age
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From 25 years old to 45 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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Sample size
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Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
Treatment Group (AF) - Oral supplementation with AF gummy for 12 weeks. Control group - Oral supplementation with placebo gummy for 12 weeks
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2022-07-27, 1401/05/05
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Ethics committee reference number
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REC/07/2022 (ST/CT/4)
Health conditions studied
1
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Description of health condition studied
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Healthy adult
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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To measure the effects of AF on plasma glucose, HbA1c and insulin levels, lipid profile, liver and kidney functions of healthy adults.
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Timepoint
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baseline, after 6-week, after 12-weeks
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Method of measurement
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blood
2
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Description
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To measure the effects of AF on resting blood pressure, body weight, fat percentage and waist to hip ratio in healthy adults
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Timepoint
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baseline, after 6-weeks, after 12- weeks
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Method of measurement
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anthropometric measurement
3
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Description
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To assess the effect of AF on cognitive function in healthy adults,
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Timepoint
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baseline, after 6-weeks, after 12-weeks
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Method of measurement
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mini mental state examination
4
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Description
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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.
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Timepoint
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baseline, after 12-weeks
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Method of measurement
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serum blood
5
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Description
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To measure the effects of AF on lung volume and capacity in healthy adults
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Timepoint
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baseline, after 6-weeks, after 12-weeks
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Method of measurement
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spirometry
6
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Description
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To observe the effect of AF on an oxidative enzymes in healthy adults
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Timepoint
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Baseline, 6-week and after 12-week
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Method of measurement
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serum blood
7
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Description
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To observe the effect of AF on diet (24 hours recall) in healthy adults
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Timepoint
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baseline, 6- week and after 12-week
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Method of measurement
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ButriPro assessment on 24 hour diet recall
8
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Description
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To observe the effect of AF on IL-6 and IL-1beta in healthy adults.
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Timepoint
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after 12-week
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Method of measurement
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serum blood
Secondary outcomes
1
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Description
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To profile the composition of the gut microbiome following a 12-week AF supplementation in healthy adults using 16s metagenomics sequencing.
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Timepoint
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after 12-weeks
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Method of measurement
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feces
2
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Description
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To identify key bacterial genera that can be potentially involved in mediating effect of AF on biochemistry and clinical parameter in healthy adults
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Timepoint
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after 12-week
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Method of measurement
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serum blood
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Industrial Grant - As Sunnah Global Ventures Sdn. Bhd. [1430503-U]
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Grant code / Reference number
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100-TNCPI/PRI 16/6/2 (014/2022)
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Universiti Teknologi MARA
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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"Affiyah" data will be kept for the use of research only
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When the data will become available and for how long
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data will be available when the data collection finish and will be kept for 7 years
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To whom data/document is available
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only for the group members of this research
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Under which criteria data/document could be used
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for research only
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From where data/document is obtainable
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from the Principal Investigator
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What processes are involved for a request to access data/document
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An official letter will be needed and the reason(s) for the request
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Comments
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No