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

NCT01306422 | Completed

• 1 other identifier: 07044V
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite Depressant; Overweight; Body Weight

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  15 days

Secondary Outcomes (1)

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

  41 days

Study Arms (6)

Stage 2: Placebo

PLACEBO COMPARATOR

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

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

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

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

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

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

Other: Hoodia gordonii purified extract (H.g.PE)

Interventions

Hoodia gordonii purified extract (H.g.PE) OTHER

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

Also known as: PYM50717, H.g.PE, Hoodia gordonii Purified Extract

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

Placebo yogurt drink OTHER

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.

Stage 2: Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unilever R&D: lead
• Phytopharm: collaborator
• Covance: collaborator

Study Sites (1)

Covance CRU

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 21993434 DERIVED

MeSH Terms

Conditions

Anorexia; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Debra Mandarino, MD

  Covance CRU, Madison WI

  PRINCIPAL INVESTIGATOR

• Leo Abrahamse, PhD

  Unilever R&D Vlaardingen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 1, 2011
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

US (1)