ObesityYGDNCT02185638
Appetite Suppression Effects of an Herbal Combination of Yerba maté, Guarana, Damiana (YGD), and 12 Other Herbal Components, Versus YGD Supplementation Alone
A study testing Appetite suppressant properties of YGD and A20-50 in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Appetite suppressant properties of YGD and A20-50
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- BMI: 27-32 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic (< 10 h hard physical activity),
Who cannot join
- BMI <27 and > 32 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- Suffering from metabolic diseases,
- Suffering from psychiatric diseases,
- Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
Show all 9Show fewer
- Hemoglobin < 7.0 mmol/l.
- alcohol and drug abuse
- blood donation, 3mo prior to the present study and during study participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department Of Human Nutrition, Faculty of Science, University of Copenhagen
Frederiksberg, 1958
About this study
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.
Read more
Aim:
To evaluate the effect of YGD combination or Akavar 20-50 (A20-50) compared with placebo on:
- Acute change in 4-h subjective appetite sensations
- Acute change in ad libitum energy intake (EI) 30 minutes post intake
- 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 kg/m2) women(age: 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:
- YGD capsules
- A20-50 capsules
- 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 subject's 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 (2.5 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).
- Conditions
- Obesity
- Being tested
- Appetite suppressant properties of YGD and A20-50
- Keywords
- obesity, herbal bioactive compounds, appetite, GLP-1, ghrelin, CCK
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appetite suppressant properties of YGD and A20-50Other
3-arm crossover study for investigation of the effect of herbal supplements A20-50 compared to YGD blend and placebo on subjective appetite sensations, glucose, insulin, ghrelin, GLP-1, CCK and ad libitum energy intake
| Study group | Role | What they receive |
|---|---|---|
| A20-50 | Experimental | A20-50 (2 capsules). Each capsule contains:
Yerba Mate (Ilex paraguariensis), Guarana seed (Paullinia cupana), Magnesium Oxide , Caffeine , Damiana (Turnera microphylla), Green tea (Camellia sinensis), Ginger (Zingiber Officinale), Kola nut (Cola acuminate or nitida), Pyridoxine Hydrochloride, Tibetan Ginseng root (Rhodiola crenulata), Schisandra (Schisandra Chinensis), Jujube (Ziziphus Jujuba) , Cocoa nut (Theobroma cacao), Chinese Skullcap (Scutellaria Baicalensis), Black tea leaf (Thea sinensis), Rice flour (to fill)
Dose = 2 capsules have a total of 200 mg of caffeine Receives: Other: Appetite suppressant properties of YGD and A20-50 |
| YGD | Active comparator | YGD blend (2 capsules). Each capsule contains:
Yerba Maté (leaf) , Guarana (seed) , Damiana (leaf) , Rice flour: to fill ,
The 2 capsules of the YGD blend contain about 40 mg xanthines (caffeine and caffeine-like stimulants). Receives: Other: Appetite suppressant properties of YGD and A20-50 |
| Placebo | Placebo comparator | Placebo (2 capsules). Each capsule contains:
Rice Flour Receives: Other: Appetite suppressant properties of YGD and A20-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake.
Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score.
Measured: Measured on 3 seperate test days in a crossover design. Each test day is seperated by >4 weeks. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake
Secondary outcomes (13)
Acute 3-h changes from baseline in subjective sensory desires using visual analogue scales
Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake.
Measured subjective sensory desires for something sweet, salty, rich in fat, or meat/fish
Measured: Measured on 3 seperate test days in a crossover design. Each test day is seperated by >4 weeks. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake
Acute 3-h changes from baseline in the postprandial concentration of Ghrelin
A venflon catheter was secured into the participants' antecubital vein, and a blood sample was taken (baseline). Immediately after the subjects were served the test compound (2 capsules). Blood samples were taken at 15 and 30 minutes after intake of the test compound (2 capsules). After 30 minutes post test compound consumption (time 0), the subjects were given a standard breakfast (2.0 MJ: bun with cheese, yoghurt, 200 ml orange juice). Additional blood samples were taken 15, 30, 45, 60, 90, 120, 150, 180 and 240 minutes post-meal
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Ghrelin was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of GLP-1
A venflon catheter was secured into the participants' antecubital vein, and a blood sample was taken (baseline). Immediately after the subjects were served the test compound (2 capsules). Blood samples were taken at 15 and 30 minutes after intake of the test compound (2 capsules). After 30 minutes post test compound consumption (time 0), the subjects were given a standard breakfast (2.0 MJ: bun with cheese, yoghurt, 200 ml orange juice). Additional blood samples were taken 15, 30, 45, 60, 90, 120, 150, 180 and 240 minutes post-meal
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. GLP-1 was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of CCK
A venflon catheter was secured into the participants' antecubital vein, and a blood sample was taken (baseline). Immediately after the subjects were served the test compound (2 capsules). Blood samples were taken at 15 and 30 minutes after intake of the test compound (2 capsules). After 30 minutes post test compound consumption (time 0), the subjects were given a standard breakfast (2.0 MJ: bun with cheese, yoghurt, 200 ml orange juice). Additional blood samples were taken 15, 30, 45, 60, 90, 120, 150, 180 and 240 minutes post-meal
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. CCK was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of glucose
A venflon catheter was secured into the participants' antecubital vein, and a blood sample was taken (baseline). Immediately after the subjects were served the test compound (2 capsules). Blood samples were taken at 15 and 30 minutes after intake of the test compound (2 capsules). After 30 minutes post test compound consumption (time 0), the subjects were given a standard breakfast (2.0 MJ: bun with cheese, yoghurt, 200 ml orange juice). Additional blood samples were taken 15, 30, 45, 60, 90, 120, 150, 180 and 240 minutes post-meal
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Glucose was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of insulin
A venflon catheter was secured into the participants' antecubital vein, and a blood sample was taken (baseline). Immediately after the subjects were served the test compound (2 capsules). Blood samples were taken at 15 and 30 minutes after intake of the test compound (2 capsules). After 30 minutes post test compound consumption (time 0), the subjects were given a standard breakfast (2.0 MJ: bun with cheese, yoghurt, 200 ml orange juice). Additional blood samples were taken 15, 30, 45, 60, 90, 120, 150, 180 and 240 minutes post-meal
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Insulin was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Change in ad libitum energy intake (EI)
240 min after each test meal an ad libitum meal was served, and the total energy intake was recorded
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. EI was measured 240 min after intake of the breakfast meal.
Rating of the organoleptic quality of the ad libitum meal
After completion of the adlibitum meal the subjects will rate the organoleptic quality of the meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
After completion of the ad libitum meal the subjects will rate the subjective appetite sensations by visual analogue scales (VAS) in regard to sensation of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to eat something sweet, salty, rich in fat, or meat/fish.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.After completion of the ad libitum meal subjects will rate their subjective sensation of appetite
change in body weight
body weight will be measured to the nearest 0.05 kg on a decimal scale.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day body weight is carried out prior to the test.
change in heart rate
heart rate were measured using an automatically inflating cuff.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day blood pressure and heart rate carried out prior to the test.
change in blood pressure
blood pressure were measured using an automatically inflating cuff.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day blood psure and heart rate carried out prior to the test.
change in composition (fat mass and fat free mass)
Body composition will be assessed by electric bioimpedance using an Animeter.
Measured: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day composition is carried out prior to the test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Dr Med, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185638
- Sponsor's protocol ID
- B258
- Acronym
- YGD
- Status last verified
- Jul 2014
- First submitted
- 19 Jun 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Suppression Effects of an Herbal Combination of Yerba maté, Guarana, Damiana (YGD), and 12 Other Herbal Components, Versus YGD Supplementation Alone
- ClinicalTrials.gov ID
- NCT02185638
- Acronym / sponsor ID
- YGD / B258
- Conditions
- Obesity
- Keywords
- obesity, herbal bioactive compounds, appetite, GLP-1, ghrelin, CCK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Acute change in 4-h subjective appetite sensations
- Acute change in ad libitum energy intake (EI) 30 minutes post intake
- 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 kg/m2) women(age: 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:
- YGD capsules
- A20-50 capsules
- 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 subject's 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 (2.5 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).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A20-50 | Experimental | Other: Appetite suppressant properties of YGD and A20-50A20-50 (2 capsules). Each capsule contains: Yerba Mate (Ilex paraguariensis), Guarana seed (Paullinia cupana), Magnesium Oxide , Caffeine , Damiana (Turnera microphylla), Green tea (Camellia sinensis), Ginger (Zingiber Officinale), Kola nut (Cola acuminate or nitida), Pyridoxine Hydrochloride, Tibetan Ginseng root (Rhodiola crenulata), Schisandra (Schisandra Chinensis), Jujube (Ziziphus Jujuba) , Cocoa nut (Theobroma cacao), Chinese Skullcap (Scutellaria Baicalensis), Black tea leaf (Thea sinensis), Rice flour (to fill) Dose = 2 capsules have a total of 200 mg of caffeine |
| YGD | Active comparator | Other: Appetite suppressant properties of YGD and A20-50YGD blend (2 capsules). Each capsule contains: Yerba Maté (leaf) , Guarana (seed) , Damiana (leaf) , Rice flour: to fill , The 2 capsules of the YGD blend contain about 40 mg xanthines (caffeine and caffeine-like stimulants). |
| Placebo | Placebo comparator | Other: Appetite suppressant properties of YGD and A20-50Placebo (2 capsules). Each capsule contains: Rice Flour |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy,
- BMI: 27-32 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic (< 10 h hard physical activity),
Key exclusion criteria (9 listed)
- BMI <27 and > 32 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- Suffering from metabolic diseases,
- Suffering from psychiatric diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appetite suppressant properties of YGD and A20-503-arm crossover study for investigation of the effect of herbal supplements A20-50 compared to YGD blend and placebo on subjective appetite sensations, glucose, insulin, ghrelin, GLP-1, CCK and ad libitum energy intake | Other | A20-50, Placebo, YGD |
Primary outcome
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
Time frame: Measured on 3 seperate test days in a crossover design. Each test day is seperated by >4 weeks. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake
Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake. Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score.
13 secondary outcomes
Acute 3-h changes from baseline in subjective sensory desires using visual analogue scales
Time frame: Measured on 3 seperate test days in a crossover design. Each test day is seperated by >4 weeks. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake
Acute 3-h changes from baseline in the postprandial concentration of Ghrelin
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Ghrelin was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of GLP-1
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. GLP-1 was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of CCK
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. CCK was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of glucose
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Glucose was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Acute 3-h changes from baseline in the postprandial concentration of insulin
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. Insulin was measured prior to the test compound (time -15 and -30 min) and to the breakfast meal (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes
Change in ad libitum energy intake (EI)
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks. EI was measured 240 min after intake of the breakfast meal.
Rating of the organoleptic quality of the ad libitum meal
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.After completion of the ad libitum meal subjects will rate their subjective sensation of appetite
change in body weight
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day body weight is carried out prior to the test.
change in heart rate
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day blood pressure and heart rate carried out prior to the test.
change in blood pressure
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day blood psure and heart rate carried out prior to the test.
change in composition (fat mass and fat free mass)
Time frame: Measured on 3 seperate test days. Each test day is seperated by >4 weeks.On each test day composition is carried out prior to the test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor, Dr Med principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appetite suppressant properties of YGD and A20-50 in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales (time frame: Measured on 3 seperate test days in a crossover design. Each test day is seperated by >4 weeks. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 45, 60, 90, 120, 150, 180 and 240 minutes post intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.