The effect of an experimental prune-based nutritional supplement for reducing the body mass index in moderately overweight women

Short-term effectiveness of prunus domestica containing a nutritional supplement (PDF4) in reducing weight and improving health-related quality of life in women with pre-obesity and grade I obesity (Body Mass Index 25 kg/m2 to 35 kg/m2): A placebo-controlled, randomized pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01504995

Enrollment

Registered

2012-08-02

Start date

2012-08-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately overweight Nutritional, Metabolic, Endocrine Obesity, unspecified

Interventions

Experimental treatment: nutritional supplement PDF4 gel 40g/d for two weeks (containing prunus domestica extract) + normal food intake Control: placebo gel 40g/d for two weeks + norma

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Otherwise healthy women [American Society of Anesthesiologists (ASA) grade I / II] >18 years 2. Moderately overweight [i.e. pre-obesity (BMI 25.0 ? 29.9) and grade I obesity (BMI 30.0 ? 34.9)] according to the WHO classification 3. Capable of understanding the nature of a randomized controlled trial 4. Willing to participate and to provide written informed consent 5. Willing to comply with study-specific assessments during follow-up

Exclusion criteria

Exclusion criteria: 1. BMI 35 2. Pregnancy or lactation 3. Known allergy against any of the ingredients of the verum or placebo gel 4. Known endocrine diseases (e.g. hyper- or hypothyroidism, polycystic ovaries, disorders of the adrenal gland or hypophysis) 5. Enteric disorders and malresorption 6. Psychiatric conditions

Design outcomes

Primary

Measure	Time frame
Mean difference in BMI reduction between verum (PDF4 gel) and placebo gel two weeks after randomization	—

Secondary

Measure	Time frame
1. The average reduction in BMI four weeks after randomization, and the difference between verum and placebo 2. The change in health-related quality of life as assessed by the Short Form 8 (SF-8) questionnaire, its physical and mental component scores, and the difference to population norms two weeks after randomization 3. To assess the effect of the verum and placebo intervention on specific eating habits.	—

Measure

Time frame

1. The average reduction in BMI four weeks after randomization, and the difference between verum and placebo 2. The change in health-related quality of life as assessed by the Short Form 8 (SF-8) questionnaire, its physical and mental component scores, and the difference to population norms two weeks after randomization 3. To assess the effect of the verum and placebo intervention on specific eating habits.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026