Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02185638
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2012-06-19
Brief Title:
Appetite Suppression Effects of an Herbal Combination of Yerba maté Guarana Damiana YGD and 12 Other Herbal Components Versus YGD Supplementation Alone
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Appetite Suppression Effects of an Herbal Combination of Yerba maté Guarana Damiana YGD and 12 Other Herbal Components Versus YGD Supplementation Alone
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YGD
Brief Summary:
Background
Supplementation with the combination of Yerba maté guarana and damiana YGD has been found to slow gastric emptying by 15 to 58 and to induce a substantial weight loss over 45 days without changes in diet Enhanced gastric emptying rate has been shown to reduce the satiating effect of food and may thereby promote obesity Yerba maté and guarana are known to contain large amounts of caffeine resins saponins and tannins whereas damiana contains ethereal oils tannins and resins Caffeine belongs to a class of compounds called methylxanthines and epidemiological studies suggest that caffeine might possess weight reducing properties The sympathomimetic properties of caffeine act to some extent through α- and β-adrenoreceptors but most of the sympathoadrenergic stimulation caused by caffeine even in very small doses acts through the dual ability to antagonise adenosine and to inhibit the activity of cellular cyclic nucleotide phosphodiesterase Stimulation of the sympathetic nervous system can cause suppression of hunger enhance satiety and increase of energy expenditure covered in part by increased fat oxidation
Aim
To evaluate the effect of YGD combination or Akavar 20-50 A20-50 compared with placebo on
1 Acute change in 4-h subjective appetite sensations
2 Acute change in ad libitum energy intake EI 30 minutes post intake
3 Acute change in serum glucose insulin ghrelin and other appetite-regulating hormones glucagon-like peptide-1 GLP-1 cholecystokinin CCK
Subjects
19 healthy premenopausal overweight to obese BMI between 27 and 32 kgm2 womenage 18 to 45 years
Method
The study is designed as a 3-way crossover randomized placebo controlled double-blind study
The bioactive components will be administered as capsules containing YGD or A20-50 The placebo capsules will contain rice flower The subjects will undergo following treatments
1 YGD capsules
2 A20-50 capsules
3 Placebo capsules
On each test day the subjects will be instructed to rest in a supine position for 15 minutes before dual measures of blood pressure and HR A blood sample will be taken baseline The subjects appetite sensations will also be assessed by visual analogue scales VAS prior to intake of the test compound Immediately hereafter the subjects will be served the first dose of the test compound Blood samples will be taken at 15 and 30 minutes time 0 post test compound After 30 minutes post test compound the subjects will be given a standard breakfast 25 MJ 598 kcal Additional blood samples will be taken 15 minutes 30 45 60 90 120 150 180 and 240 minutes post-meal together with a VAS appetite score assessment 0 30 45 60 90 120 150 180 and 240 minutes
Immediately after the last blood collection subjects will be asked to take a second dose of the test compound After 30 minutes the subjects will repeat one VAS score assessment and be served an ad libitum lunch
Blood samples will be analyzed for insulin glucose and appetite regulating hormones such as glucagon-like peptide-1 GLP-1 ghrelin cholecystokinin CCK
Supplementation with the combination of Yerba maté guarana and damiana YGD has been found to slow gastric emptying by 15 to 58 and to induce a substantial weight loss over 45 days without changes in diet Enhanced gastric emptying rate has been shown to reduce the satiating effect of food and may thereby promote obesity Yerba maté and guarana are known to contain large amounts of caffeine resins saponins and tannins whereas damiana contains ethereal oils tannins and resins Caffeine belongs to a class of compounds called methylxanthines and epidemiological studies suggest that caffeine might possess weight reducing properties The sympathomimetic properties of caffeine act to some extent through α- and β-adrenoreceptors but most of the sympathoadrenergic stimulation caused by caffeine even in very small doses acts through the dual ability to antagonise adenosine and to inhibit the activity of cellular cyclic nucleotide phosphodiesterase Stimulation of the sympathetic nervous system can cause suppression of hunger enhance satiety and increase of energy expenditure covered in part by increased fat oxidation
Aim
To evaluate the effect of YGD combination or Akavar 20-50 A20-50 compared with placebo on
1 Acute change in 4-h subjective appetite sensations
2 Acute change in ad libitum energy intake EI 30 minutes post intake
3 Acute change in serum glucose insulin ghrelin and other appetite-regulating hormones glucagon-like peptide-1 GLP-1 cholecystokinin CCK
Subjects
19 healthy premenopausal overweight to obese BMI between 27 and 32 kgm2 womenage 18 to 45 years
Method
The study is designed as a 3-way crossover randomized placebo controlled double-blind study
The bioactive components will be administered as capsules containing YGD or A20-50 The placebo capsules will contain rice flower The subjects will undergo following treatments
1 YGD capsules
2 A20-50 capsules
3 Placebo capsules
On each test day the subjects will be instructed to rest in a supine position for 15 minutes before dual measures of blood pressure and HR A blood sample will be taken baseline The subjects appetite sensations will also be assessed by visual analogue scales VAS prior to intake of the test compound Immediately hereafter the subjects will be served the first dose of the test compound Blood samples will be taken at 15 and 30 minutes time 0 post test compound After 30 minutes post test compound the subjects will be given a standard breakfast 25 MJ 598 kcal Additional blood samples will be taken 15 minutes 30 45 60 90 120 150 180 and 240 minutes post-meal together with a VAS appetite score assessment 0 30 45 60 90 120 150 180 and 240 minutes
Immediately after the last blood collection subjects will be asked to take a second dose of the test compound After 30 minutes the subjects will repeat one VAS score assessment and be served an ad libitum lunch
Blood samples will be analyzed for insulin glucose and appetite regulating hormones such as glucagon-like peptide-1 GLP-1 ghrelin cholecystokinin CCK
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None