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

Sponsor

Unilever R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT01306422

Collaborator

Phytopharm (Industry), Covance (Industry)

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appetite Depressant Overweight Body Weight	Other: Hoodia gordonii purified extract (H.g.PE) Other: Placebo yogurt drink Other: Placebo yogurt drink Other: Placebo yogurt drink Other: Hoodia gordonii purified extract (H.g.PE) Other: Hoodia gordonii purified extract (H.g.PE)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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 Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Stage 2: Placebo Placebo product, twice-daily, 65 minutes before breakfast and dinner	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.
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	Other: 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 Other Names: PYM50717 H.g.PE Hoodia gordonii Purified Extract
Placebo Comparator: Stage 1: placebo, breakfast & dinner Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner	Other: Placebo yogurt drink 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	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 Other Names: PYM50717 H.g.PE Hoodia gordonii Purified Extract
Placebo Comparator: stage 1: Placebo breakfast/lunch Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch	Other: Placebo yogurt drink Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
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	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 Other Names: PYM50717 H.g.PE Hoodia gordonii Purified Extract

Outcome Measures

Primary Outcome Measures

Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE) [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
Efficacy of 15-day repeat consumption of H.g.PE [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.

Secondary Outcome Measures

Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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