Berberine
Dietary SupplementBerberine supplement 500 mg 2 x per day
NCT Number: NCT07541898
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Berberine supplement 500 mg 2 x per day
Placebo control 2 x blinded placebo tablet per day
Time frame: Baseline
Capillary blood triglycerides - mmol/L
Time frame: 20-days
Capillary blood triglycerides - mmol/L
Time frame: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20-days
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: 20-days
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: Baseline
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: 20-days
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: Baseline
Capillary blood glucose - mmol/L
Time frame: 20-days
Capillary blood glucose - mmol/L
Time frame: Baseline
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: 20-days
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time frame: Baseline
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Capillary blood cholesterol - mmol/L
Time frame: 20-days
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: 20-days
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Time frame: Baseline
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
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
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
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
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
University of Central Lancashire
Other
Effects of Berberine Supplementation on Cardiometabolic Parameters
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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