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

Primary Purpose

Appetite Depressant, Overweight, Body Weight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hoodia gordonii purified extract (H.g.PE)

Placebo yogurt drink

Hoodia gordonii purified extract (H.g.PE)

About this trial

This is an interventional basic science trial for Appetite Depressant focused on measuring hoodia gordonii, energy intake, food intake, efficacy, body weight, functional food, plant extract, safety, steroid glycosides, tolerability

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Covance CRU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Stage 2: Placebo

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

Stage 1: placebo, breakfast & dinner

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

stage 1: Placebo breakfast/lunch

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

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

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

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

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.

Full Information

NCT ID

NCT01306422

First Posted

February 25, 2011

Last Updated

February 28, 2011

Sponsor

Unilever R&D

Collaborators

Phytopharm, Covance

1. Study Identification

Unique Protocol Identification Number

NCT01306422

Brief Title

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

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Unilever R&D

Collaborators

Phytopharm, Covance

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appetite Depressant, Overweight, Body Weight

Keywords

hoodia gordonii, energy intake, food intake, efficacy, body weight, functional food, plant extract, safety, steroid glycosides, tolerability

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stage 2: Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Stage 1: placebo, breakfast & dinner

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

stage 1: Placebo breakfast/lunch

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Hoodia gordonii purified extract (H.g.PE)

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo yogurt drink

Intervention Description

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

Intervention Name(s)

Placebo yogurt drink

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo yogurt drink

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hoodia gordonii purified extract (H.g.PE)

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hoodia gordonii purified extract (H.g.PE)

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

41 days

Title

Efficacy of 15-day repeat consumption of H.g.PE

Description

Time Frame

15 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

41 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra Mandarino, MD

Organizational Affiliation

Covance CRU, Madison WI

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leo Abrahamse, PhD

Organizational Affiliation

Unilever R&D Vlaardingen

Official's Role

Study Chair

Facility Information:

Facility Name

Covance CRU

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21993434

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.

Results Reference

derived

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

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