NCT01306422

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Appetite Depressant
• Overweight
• Body Weight

Interventions

Type	Name	Description
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	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	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

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2011-03-01
• Last updated: 2011-03-01

Locations

1 site across 1 country: United States