Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Berberine may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: 20-days
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: Baseline
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: 20-days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
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Time frame: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: 20-days
Blood glucose
Capillary blood glucose - mmol/L
Time frame: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Time frame: 20-days
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: Baseline
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: 20-days
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - Total
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - LDL
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol - HDL
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: Baseline
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: 20-days
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Time frame: Baseline
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Time frame: 20-days
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Time frame: Baseline
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Time frame: 20-days
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Time frame: Baseline
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Time frame: 20-days
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Time frame: Baseline
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Time frame: 20-days
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Time frame: Baseline
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Time frame: 20-days