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

This study has been completed.
Sponsor:
Collaborators:
Phytopharm
Covance
Information provided by:
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01306422
First received: February 25, 2011
Last updated: February 28, 2011
Last verified: February 2011

February 25, 2011
February 28, 2011
March 2008
July 2008   (final data collection date for primary outcome measure)
  • Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE) [ Time Frame: 41 days ] [ Designated as safety issue: Yes ]
    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
  • Efficacy of 15-day repeat consumption of H.g.PE [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01306422 on ClinicalTrials.gov Archive Site
Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE [ Time Frame: 41 days ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
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)

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Appetite Depressant
  • Overweight
  • Body Weight
  • 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
  • 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.
  • Other: Placebo yogurt drink
    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 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 lunch
    Other Names:
    • PYM50717
    • H.g.PE
    • Hoodia gordonii Purified Extract
  • 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 2: Placebo
    Placebo product, twice-daily, 65 minutes before breakfast and dinner
    Intervention: Other: Placebo yogurt drink
  • 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
    Intervention: Other: Hoodia gordonii purified extract (H.g.PE)
  • Placebo Comparator: Stage 1: placebo, breakfast & dinner
    Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
    Intervention: Other: Placebo yogurt drink
  • 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
    Intervention: Other: Hoodia gordonii purified extract (H.g.PE)
  • Placebo Comparator: stage 1: Placebo breakfast/lunch
    Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
    Intervention: Other: Placebo yogurt drink
  • 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
    Intervention: Other: Hoodia gordonii purified extract (H.g.PE)
Blom WA, Abrahamse SL, Bradford R, Duchateau GS, Theis W, Orsi A, Ward CL, Mela DJ. Effects of 15-d repeated consumption of Hoodia gordonii purified extract on safety, ad libitum energy intake, and body weight in healthy, overweight women: a randomized controlled trial. Am J Clin Nutr. 2011 Nov;94(5):1171-81. doi: 10.3945/ajcn.111.020321. Epub 2011 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01306422
07044V
No
Leo Abrahamse, PhD, Unilever R&D Vlaardingen
Unilever R&D
  • Phytopharm
  • Covance
Principal Investigator: Debra Mandarino, MD Covance CRU, Madison WI
Study Chair: Leo Abrahamse, PhD Unilever R&D Vlaardingen
Unilever R&D
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP