- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306422
Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
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)
Study Overview
Status
Conditions
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Covance CRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Stage 2: Placebo
Placebo product, twice-daily, 65 minutes before breakfast and dinner
|
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.
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
|
Active Comparator: 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
|
H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Other Names:
|
Placebo Comparator: Stage 1: placebo, breakfast & dinner
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
|
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.
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
|
Active Comparator: 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
|
H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Other Names:
|
Placebo Comparator: stage 1: Placebo breakfast/lunch
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
|
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.
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
|
Active Comparator: 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
|
H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
Other Names:
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE)
Time Frame: 41 days
|
Safety and tolerability (Adverse Events (AEs), vitals signs, Electrocardiogram (ECG), laboratory assessments) of twice daily consumption of 1110 mg of formulated Hoodia gordonii purified extract (H.g.PE) consumed over a period of 2 or 15 days were assessed up to 41 days after start of the intervention
|
41 days
|
Efficacy of 15-day repeat consumption of H.g.PE
Time Frame: 15 days
|
Efficacy of twice daily consumption of 1110 mg of formulated H.g.PE during 15-day repeat intake was assessed.
Appetite scores, ad libitum energy intake, body weight and body composition were assessed during the 15-day intervention.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE
Time Frame: 41 days
|
Kinetic parameters were calculated on Days 5 and 19 based on the individual plasma concentration-time profiles of the steroid glycoside, PYM50057.
Maximum measured plasma concentration (Cmax), time of Cmax (tmax), area under the concentration-time curve (AUC), apparent terminal phase rate constant (Kel), absorption rate constant (Ka),the apparent first order elimination rate constant (λz) and the overall apparent elimination half-life (t1/2) were assessed.
Samples were taken up to 41 days after start of the intervention.
|
41 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Debra Mandarino, MD, Covance CRU, Madison WI
- Study Chair: Leo Abrahamse, PhD, Unilever R&D Vlaardingen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07044V
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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