Appetite DepressantNCT01306422
Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
A study testing Hoodia gordonii purified extract (H.g.PE) in people with Appetite Depressant and Overweight, run by Unilever R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Depressant, Overweight, Body Weight
- What is being tested?
- Hoodia gordonii purified extract (H.g.PE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Appetite Depressant, Overweight, Body Weight
- Being tested
- Hoodia gordonii purified extract (H.g.PE), Placebo yogurt drink
- Keywords
- hoodia gordonii, energy intake, food intake, efficacy, body weight, functional food, plant extract, safety, steroid glycosides, tolerability
- Medical subject headings
- Anorexia, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoodia gordonii purified extract (H.g.PE)Other
Also called PYM50717, H.g.PE, Hoodia gordonii Purified Extract
H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
Placebo yogurt drinkOther
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 yogurt drinkOther
Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
Placebo yogurt drinkOther
Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
Hoodia gordonii purified extract (H.g.PE)Other
Also called PYM50717, H.g.PE, Hoodia gordonii Purified Extract
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
Hoodia gordonii purified extract (H.g.PE)Other
Also called PYM50717, H.g.PE, Hoodia gordonii Purified Extract
H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| Stage 2: Placebo | Placebo comparator | Placebo product, twice-daily, 65 minutes before breakfast and dinner Receives: Other: Placebo yogurt drink |
| Stage 2: H.g.PE 1110 mg b.d. | Active comparator | Hoodia gordonii Purified Extract (H.g.PE) formulated product (1110 mg), twice-daily, 65 minutes before breakfast and dinner Receives: Other: Hoodia gordonii purified extract (H.g.PE) |
| Stage 1: placebo, breakfast & dinner | Placebo comparator | Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner Receives: Other: Placebo yogurt drink |
| Stage 1: H.g.PE 1110 mg breakfast/dinner | Active comparator | Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner Receives: Other: Hoodia gordonii purified extract (H.g.PE) |
| stage 1: Placebo breakfast/lunch | Placebo comparator | Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch Receives: Other: Placebo yogurt drink |
| Stage 1: H.g.PE 1110 mg breakfast/lunch | Active comparator | Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch Receives: Other: Hoodia gordonii purified extract (H.g.PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 41 days
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.
Measured: 15 days
Secondary outcomes (1)
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.
Measured: 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2008
- Primary completionJul 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite DepressantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phytopharm, Covance
- Investigators
- Debra Mandarino, MD, Principal investigator, Covance CRU, Madison WILeo Abrahamse, PhD, Study chair, Unilever R&D Vlaardingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306422
- Sponsor's protocol ID
- 07044V
- Status last verified
- Feb 2011
- First submitted
- 25 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21993434
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01306422
- Acronym / sponsor ID
- 07044V
- Conditions
- Appetite Depressant, Overweight, Body Weight
- Keywords
- hoodia gordonii, energy intake, food intake, efficacy, body weight, functional food, plant extract, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Phytopharm, Covance
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage 2: Placebo | Placebo comparator | Other: Placebo yogurt drinkPlacebo product, twice-daily, 65 minutes before breakfast and dinner |
| Stage 2: H.g.PE 1110 mg b.d. | Active comparator | Other: Hoodia gordonii purified extract (H.g.PE)Hoodia gordonii Purified Extract (H.g.PE) formulated product (1110 mg), twice-daily, 65 minutes before breakfast and dinner |
| Stage 1: placebo, breakfast & dinner | Placebo comparator | Other: Placebo yogurt drinkPlacebo product, twice-daily for two days, 65 minutes before breakfast and dinner |
| Stage 1: H.g.PE 1110 mg breakfast/dinner | Active comparator | Other: Hoodia gordonii purified extract (H.g.PE)Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner |
| stage 1: Placebo breakfast/lunch | Placebo comparator | Other: Placebo yogurt drinkPlacebo product, twice-daily for two days, 65 minutes before breakfast and lunch |
| Stage 1: H.g.PE 1110 mg breakfast/lunch | Active comparator | Other: Hoodia gordonii purified extract (H.g.PE)Hoodia gordonii purified extract (H.g.PE) formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hoodia gordonii purified extract (H.g.PE)Also: PYM50717, H.g.PE, Hoodia gordonii Purified ExtractH.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days | Other | Stage 2: H.g.PE 1110 mg b.d. |
| Placebo yogurt drinkPlacebo 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. | Other | Stage 2: Placebo |
| Placebo yogurt drinkPlacebo product, twice-daily for two days, 65 minutes before breakfast and lunch | Other | stage 1: Placebo breakfast/lunch |
| Placebo yogurt drinkPlacebo product, twice-daily for two days, 65 minutes before breakfast and dinner | Other | Stage 1: placebo, breakfast & dinner |
| Hoodia gordonii purified extract (H.g.PE)Also: PYM50717, H.g.PE, Hoodia gordonii Purified ExtractH.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch | Other | Stage 1: H.g.PE 1110 mg breakfast/lunch |
| Hoodia gordonii purified extract (H.g.PE)Also: PYM50717, H.g.PE, Hoodia gordonii Purified ExtractH.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner | Other | Stage 1: H.g.PE 1110 mg breakfast/dinner |
Primary outcome
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
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.
1 secondary outcome
Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE
Time frame: 41 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
- Derived from this study: PubMed 21993434Blom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Mandarino, MD principal investigator
Covance CRU, Madison WI
Leo Abrahamse, PhD study chair
Unilever R&D Vlaardingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hoodia gordonii purified extract (H.g.PE) in people with Appetite Depressant and Overweight, run by Unilever R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE) (time frame: 41 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01306422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.