We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01306422
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : March 1, 2011
Sponsor:
Collaborators:
Phytopharm
Covance
Information provided by:
Unilever R&D

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this clinical study was to assess the safety, tolerability, efficacy (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified extract (H.g.PE), when consumed twice-daily for 2 or 15-days.

Condition or disease Intervention/treatment Phase
Appetite Depressant Overweight Body Weight Other: Hoodia gordonii purified extract (H.g.PE) Other: Placebo yogurt drink Not Applicable

Detailed Description:

A two stage randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, kinetics and efficacy of twice-daily repeat intake of formulated Hoodia gordonii purified extract (H.g.PE) (PYM50717) administered twice daily for 2 or 15 days to healthy, overweight females aged 18 to 50 years with a body fat of 25-45%.

Stage 1 (pilot): Placebo controlled, double blind comparison to assess the effect of timing of product administration (i.e. breakfast and lunch vs breakfast and dinner).

Stage 2 (main study): Placebo controlled double blind comparison with product administered with breakfast and dinner.

A total of 64 subjects were included in this study; stage 1: n=15, stage 2: n=49. Treatment groups in stage 2 were matched for percentage body fat.

Stage 1:

  • H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch (n = 4).
  • Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch (n = 3).
  • H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner (n = 5).
  • Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner (n = 3).

Stage 2:

  • H.g.PE formulated product (1110 mg), twice daily (n=25)for 15 days
  • Placebo product , twice daily (n=24),for 15 days
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Two Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Kinetics and Efficacy of Twice-Daily Repeat Intake of 1110 mg of Hoodia Gordonii Purified Extract (PYM50717)
Study Start Date : March 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Stage 2: Placebo
Placebo product, twice-daily, 65 minutes before breakfast and dinner
 Other: Placebo yogurt drink
Placebo product (yogurt drink matching the H.g.PE extract formulated yogurt drink in nutritional composition and taste. Placebo is consumed twice-daily, 65 minutes before breakfast and dinner for 15 days.
Active Comparator: Stage 2: H.g.PE 1110 mg b.d.
Hoodia gordonii Purified Extract (H.g.PE) formulated product (1110 mg), twice-daily, 65 minutes before breakfast and dinner
 Other: Hoodia gordonii purified extract (H.g.PE)
H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Other Names:
  • PYM50717
  • H.g.PE
  • Hoodia gordonii Purified Extract
Placebo Comparator: Stage 1: placebo, breakfast & dinner
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
 Other: Placebo yogurt drink
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
Active Comparator: Stage 1: H.g.PE 1110 mg breakfast/dinner
Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
 Other: Hoodia gordonii purified extract (H.g.PE)
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Other Names:
  • PYM50717
  • H.g.PE
  • Hoodia gordonii Purified Extract
Placebo Comparator: stage 1: Placebo breakfast/lunch
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
 Other: Placebo yogurt drink
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Active Comparator: Stage 1: H.g.PE 1110 mg breakfast/lunch
Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
 Other: Hoodia gordonii purified extract (H.g.PE)
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
Other Names:
  • PYM50717
  • H.g.PE
  • Hoodia gordonii Purified Extract


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE) [ Time Frame: 41 days ]
    Safety and tolerability (Adverse Events (AEs), vitals signs, Electrocardiogram (ECG), laboratory assessments) of twice daily consumption of 1110 mg of formulated Hoodia gordonii purified extract (H.g.PE) consumed over a period of 2 or 15 days were assessed up to 41 days after start of the intervention

  2. Efficacy of 15-day repeat consumption of H.g.PE [ Time Frame: 15 days ]
    Efficacy of twice daily consumption of 1110 mg of formulated H.g.PE during 15-day repeat intake was assessed. Appetite scores, ad libitum energy intake, body weight and body composition were assessed during the 15-day intervention.


Secondary Outcome Measures :
  1. Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE [ Time Frame: 41 days ]
    Kinetic parameters were calculated on Days 5 and 19 based on the individual plasma concentration-time profiles of the steroid glycoside, PYM50057. Maximum measured plasma concentration (Cmax), time of Cmax (tmax), area under the concentration-time curve (AUC), apparent terminal phase rate constant (Kel), absorption rate constant (Ka),the apparent first order elimination rate constant (λz) and the overall apparent elimination half-life (t1/2) were assessed. Samples were taken up to 41 days after start of the intervention.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females between the ages of 18 and 50 years.
  • Body fat between 25% and 45% as assessed by Dual Energy X-ray absorptiometry (DEXA) scan at Screening.
  • Stable body weight for at least two months prior to Screening (weight loss or gain >5% was considered unstable).
  • Regularly consumed at least three meals per day, including breakfast.
  • Agreed to abstain from strenuous exercise throughout the entire study.

Exclusion Criteria:

  • Subjects who were pregnant, lactating or were not willing to use two contraceptives (including at least one barrier contraceptive) starting at least 14 days before study product administration (Day 1) and until at least 30 days following study product administration (except subjects who were surgically sterilized or were more than one year post-menopausal).
  • Subjects who were taking any prescription or over the counter medications (with the exception of hormonal contraceptives) (including supplements, especially as related to weight management [eg, ephedrine, caffeine, synephrine]) within one week prior to Visit 2 (Day 1), or antibiotics <3 months prior to Day 1, or planned to do so during the course of the study.
  • Smokers, or ex-smokers who smoked any cigarettes in the past six months prior to study product administration and/or who used another form of nicotine-containing product.
  • Fasting blood glucose > 7 mmol/L (126 mg/dL) at Screening.
  • Psychiatric disorders that could have interfered with the subject's compliance to the requirements of the protocol, at the discretion of the Investigator.
  • Used or planned to use any medically prescribed diet or weight-loss diet or made any attempt to control diet at Screening and during the entire study.
  • Strenuous exercise >5 hours per week (eg, sports).
  • Restrained eating behavior determined by a score of ≥16 on the Revised Restraint Scale
  • a low score on the Food Action Rating Scale
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306422


Locations
Layout table for location information
United States, Wisconsin
Covance CRU
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Unilever R&D
Phytopharm
Covance
Investigators
Layout table for investigator information
Principal Investigator: Debra Mandarino, MD Covance CRU, Madison WI
Study Chair: Leo Abrahamse, PhD Unilever R&D Vlaardingen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Leo Abrahamse, PhD, Unilever R&D Vlaardingen
ClinicalTrials.gov Identifier: NCT01306422    
Other Study ID Numbers: 07044V
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011
Keywords provided by Unilever R&D:
hoodia gordonii
energy intake
food intake
efficacy
body weight
 functional food
plant extract
safety
steroid glycosides
tolerability
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight