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

Overweight Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite Depressant
• Body Weight
• Overweight

• NCT number: NCT01306422
• Study type: Interventional
• Source: Unilever R&D
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Completion date: October 2008