An interventional study of Hoodia gordonii purified extract (H.g.PE) and Placebo yogurt drink in Appetite Depressant, Overweight and Body Weight, sponsored by Unilever R&D. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-01.
Sponsored by Unilever R&D · Not applicable, Interventional, and Basic science
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:
Stage 2:
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 64 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Exclusion Criteria:
Placebo product, twice-daily, 65 minutes before breakfast and dinner
Other: Placebo yogurt drink
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)
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
Other: Placebo yogurt drink
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)
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Other: Placebo yogurt drink
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(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Also known as: PYM50717, H.g.PE, Hoodia gordonii Purified Extract
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
Also known as: PYM50717, H.g.PE, Hoodia gordonii Purified Extract
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Also known as: PYM50717, H.g.PE, Hoodia gordonii Purified Extract
Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE)
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
Time frame: 41 days
Efficacy of 15-day repeat consumption of H.g.PE
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.
Time frame: 15 days
Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE
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.
Time frame: 41 days
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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