Appetite Suppression Effects of an Herbal Combination of Yerba maté, Guarana, Damiana (YGD), and 12 Other Herbal Components, Versus YGD Supplementation Alone

NCT02185638 | Completed

• 1 other identifier: B258
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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. 1.Acute change in 4-h subjective appetite sensations
2. 2.Acute change in ad libitum energy intake (EI) 30 minutes post intake
3. 3.Acute change in serum glucose, insulin, ghrelin and other appetite-regulating hormones (glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK))
4. 4.YGD capsules
5. 5.A20-50 capsules
6. 6.Placebo capsules

Conditions

Obesity

Keywords

obesity; herbal bioactive compounds; appetite; GLP-1; ghrelin; CCK

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  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

  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

  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

Study Arms (3)

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

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).

Other: Appetite suppressant properties of YGD and A20-50

Placebo

PLACEBO COMPARATOR

Placebo (2 capsules). Each capsule contains: Rice Flour

Other: Appetite suppressant properties of YGD and A20-50

Interventions

Appetite suppressant properties of YGD and A20-50 OTHER

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

A20-50; Placebo; YGD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy,
• BMI: 27-32 kg/m2,
• Non-smoking,
• Nonathletic (\< 10 h hard physical activity),

You may not qualify if:

• 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,
• Hemoglobin \< 7.0 mmol/l.
• alcohol and drug abuse
• blood donation, 3mo prior to the present study and during study participation

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department Of Human Nutrition, Faculty of Science, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne Astrup, Professor, Dr Med

  Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr Med

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 9, 2014
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

DK (1)