Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
Condition: Appetite Depressant; Overweight; Body Weight
MeSH terms: Overweight; Body Weight
Study type: Interventional

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.
    

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
    

Intervention name(s): Hoodia gordonii purified extract (H.g.PE); Placebo yogurt drink; Placebo yogurt drink; Placebo yogurt drink; Hoodia gordonii purified extract (H.g.PE); Hoodia gordonii purified extract (H.g.PE)
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days; 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.; Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch; Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner; H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch; H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Other intervention name(s): PYM50717; H.g.PE; Hoodia gordonii Purified Extract; PYM50717; H.g.PE; Hoodia gordonii Purified Extract; PYM50717; H.g.PE; Hoodia gordonii Purified Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: hoodia gordonii; energy intake; food intake; efficacy; body weight; functional food; plant extract; safety; steroid glycosides; tolerability