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

Completed · Not applicable · Has a placebo group

Conditions studied: Appetite Depressant, Overweight, Body Weight

In brief

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.

Key facts

Study ID

NCT01306422

Run by

Unilever R&D

People needed

64

Starts

2008-03-01

Expected to finish

2008-10-01

Last updated by the study team

2011-03-01

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy females between the ages of 18 and 50 years.
• Body fat between 25% and 45% as assessed by Dual Energy X-ray absorptiometry (DEXA) scan at Screening.
• Stable body weight for at least two months prior to Screening (weight loss or gain >5% was considered unstable).
• Regularly consumed at least three meals per day, including breakfast.
• Agreed to abstain from strenuous exercise throughout the entire study.

You may not qualify if…

• Subjects who were pregnant, lactating or were not willing to use two contraceptives (including at least one barrier contraceptive) starting at least 14 days before study product administration (Day 1) and until at least 30 days following study product administration (except subjects who were surgically sterilized or were more than one year post-menopausal).
• Subjects who were taking any prescription or over the counter medications (with the exception of hormonal contraceptives) (including supplements, especially as related to weight management [eg, ephedrine, caffeine, synephrine]) within one week prior to Visit 2 (Day 1), or antibiotics <3 months prior to Day 1, or planned to do so during the course of the study.
• Smokers, or ex-smokers who smoked any cigarettes in the past six months prior to study product administration and/or who used another form of nicotine-containing product.
• Fasting blood glucose > 7 mmol/L (126 mg/dL) at Screening.
• Psychiatric disorders that could have interfered with the subject's compliance to the requirements of the protocol, at the discretion of the Investigator.
• Used or planned to use any medically prescribed diet or weight-loss diet or made any attempt to control diet at Screening and during the entire study.
• Strenuous exercise >5 hours per week (eg, sports).
• Restrained eating behavior determined by a score of ≥16 on the Revised Restraint Scale
• a low score on the Food Action Rating Scale

Where it is running

• Covance CRU — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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