Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
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About
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.
Full 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
Enrollment
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Inclusion criteria
- 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.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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