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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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

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Appetite Depressant Overweight Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Stage 2: Placebo

Placebo product, twice-daily, 65 minutes before breakfast and dinner

Group Type PLACEBO_COMPARATOR

Placebo yogurt drink

Intervention Type OTHER

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.

Stage 2: H.g.PE 1110 mg b.d.

Hoodia gordonii Purified Extract (H.g.PE) formulated product (1110 mg), twice-daily, 65 minutes before breakfast and dinner

Group Type ACTIVE_COMPARATOR

Hoodia gordonii purified extract (H.g.PE)

Intervention Type OTHER

H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days

Stage 1: placebo, breakfast & dinner

Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner

Group Type PLACEBO_COMPARATOR

Placebo yogurt drink

Intervention Type OTHER

Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner

Stage 1: H.g.PE 1110 mg breakfast/dinner

Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner

Group Type ACTIVE_COMPARATOR

Hoodia gordonii purified extract (H.g.PE)

Intervention Type OTHER

H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner

stage 1: Placebo breakfast/lunch

Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch

Group Type PLACEBO_COMPARATOR

Placebo yogurt drink

Intervention Type OTHER

Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch

Stage 1: H.g.PE 1110 mg breakfast/lunch

Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch

Group Type ACTIVE_COMPARATOR

Hoodia gordonii purified extract (H.g.PE)

Intervention Type OTHER

H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Placebo yogurt drink

Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch

Intervention Type OTHER

Placebo yogurt drink

Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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PYM50717 H.g.PE Hoodia gordonii Purified Extract PYM50717 H.g.PE Hoodia gordonii Purified Extract PYM50717 H.g.PE Hoodia gordonii Purified Extract

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes