Clinical trial NCT01306422: Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Depressant
Overweight
Body Weight
Keywords: hoodia gordonii
energy intake
food intake
efficacy
body weight
functional food
plant extract
safety
steroid glycosides
tolerability
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Phytopharm
name: Covance
First posted: 2011-03-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE)
timeFrame: 41 days
measure: Efficacy of 15-day repeat consumption of H.g.PE
timeFrame: 15 days
Secondary outcomes:
measure: Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE
timeFrame: 41 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance CRU
state: Wisconsin
Study officials:
affiliation: Covance CRU, Madison WI
name: Debra Mandarino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unilever R&D Vlaardingen
name: Leo Abrahamse, PhD
role: STUDY_CHAIR
References:
citation: Blom WA, Abrahamse SL, Bradford R, Duchateau GS, Theis W, Orsi A, Ward CL, Mela DJ. Effects of 15-d repeated consumption of Hoodia gordonii purified extract on safety, ad libitum energy intake, and body weight in healthy, overweight women: a randomized controlled trial. Am J Clin Nutr. 2011 Nov;94(5):1171-81. doi: 10.3945/ajcn.111.020321. Epub 2011 Oct 12.