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

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.

Conditions

• Appetite Depressant
• Overweight
• Body Weight

Interventions

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

Sponsors & Collaborators

• Phytopharm

  collaborator INDUSTRY

• Covance

  collaborator INDUSTRY

• Unilever R&D

  lead INDUSTRY

Principal Investigators

• Debra Mandarino, MD · Covance CRU, Madison WI

• Leo Abrahamse, PhD · Unilever R&D Vlaardingen

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2008-07-31

Completion

2008-10-31

Countries

• United States

Study Locations