Limits...
Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial.

Loftus HL, Astell KJ, Mathai ML, Su XQ - Nutrients (2015)

Bottom Line: Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention.Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups.The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group.

View Article: PubMed Central - PubMed

Affiliation: Centre for Chronic Disease, College of Health and Biomedicine, Victoria University, P.O. BOX 14428 MCMC, Melbourne 8001, Australia. hayley.loftus@live.vu.edu.au.

ABSTRACT
Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI), waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

No MeSH data available.


Related in: MedlinePlus

Flow chart of study design.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4663611&req=5

nutrients-07-05483-f002: Flow chart of study design.

Mentions: This study was a double blind, placebo-controlled randomized clinical trial conducted at Victoria University, Melbourne, Australia. Participants were recruited through the general community, staff members and students from May to July 2014. Forty-one overweight or obese participants (12 males and 29 females) were enrolled in the trial (Figure 2). All participants were screened to assess eligibility prior to enrolling and informed written consent was obtained. The eligibility criteria included: BMI > 25 m² or waist circumference > 94 cm (male) and > 80 cm (female), 20–65 years, non-smoker, non-pregnant or lactating, non-type 1 diabetic, no present liver, kidney or heart disease, not susceptible to peptic ulcers and not taking any medication for weight loss, hypertension or thrombocytosis. Prior to randomization, an initial assessment was conducted to measure participant’s weight, height, waist and hip circumference, blood pressure (BP) and heart rate (HR). BMI and waist-to-hip ratio (WHR) were then calculated. This information was used to randomly allocate participants into either the treatment or the control group by the chief investigator. Stratification method of randomization was carried out to ensure that the baseline characteristics were evenly distributed amongst groups to avoid potential confounding results. The method used to ensure allocation concealment was sequentially numbered containers. The containers were equal in weight, similar in appearance and tamper-proof. The principal investigator implemented the allocation sequence and assigned the participants into their groups. The capsules were opaque and indistinguishable in appearance, size, texture and smell. The taste of the capsules was identical provided that they were swallowed whole as instructed. Staff and participants involved in the intervention process of the trial were blinded to group assignment. The randomization code was broken only after data analysis was completed. The study was approved by the Human Ethics Research Committee of Victoria University (VUHERC approval number 14-020). Trial registration: Australia New Zealand Clinical Trial Registry (ANZCTR): ACTRN12614000305628.


Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial.

Loftus HL, Astell KJ, Mathai ML, Su XQ - Nutrients (2015)

Flow chart of study design.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4663611&req=5

nutrients-07-05483-f002: Flow chart of study design.
Mentions: This study was a double blind, placebo-controlled randomized clinical trial conducted at Victoria University, Melbourne, Australia. Participants were recruited through the general community, staff members and students from May to July 2014. Forty-one overweight or obese participants (12 males and 29 females) were enrolled in the trial (Figure 2). All participants were screened to assess eligibility prior to enrolling and informed written consent was obtained. The eligibility criteria included: BMI > 25 m² or waist circumference > 94 cm (male) and > 80 cm (female), 20–65 years, non-smoker, non-pregnant or lactating, non-type 1 diabetic, no present liver, kidney or heart disease, not susceptible to peptic ulcers and not taking any medication for weight loss, hypertension or thrombocytosis. Prior to randomization, an initial assessment was conducted to measure participant’s weight, height, waist and hip circumference, blood pressure (BP) and heart rate (HR). BMI and waist-to-hip ratio (WHR) were then calculated. This information was used to randomly allocate participants into either the treatment or the control group by the chief investigator. Stratification method of randomization was carried out to ensure that the baseline characteristics were evenly distributed amongst groups to avoid potential confounding results. The method used to ensure allocation concealment was sequentially numbered containers. The containers were equal in weight, similar in appearance and tamper-proof. The principal investigator implemented the allocation sequence and assigned the participants into their groups. The capsules were opaque and indistinguishable in appearance, size, texture and smell. The taste of the capsules was identical provided that they were swallowed whole as instructed. Staff and participants involved in the intervention process of the trial were blinded to group assignment. The randomization code was broken only after data analysis was completed. The study was approved by the Human Ethics Research Committee of Victoria University (VUHERC approval number 14-020). Trial registration: Australia New Zealand Clinical Trial Registry (ANZCTR): ACTRN12614000305628.

Bottom Line: Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention.Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups.The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group.

View Article: PubMed Central - PubMed

Affiliation: Centre for Chronic Disease, College of Health and Biomedicine, Victoria University, P.O. BOX 14428 MCMC, Melbourne 8001, Australia. hayley.loftus@live.vu.edu.au.

ABSTRACT
Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI), waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

No MeSH data available.


Related in: MedlinePlus