Plain English Summary
Background and study aims
In overweight individuals reducing weight prevents or improves common chronic diseases like diabetes (high blood sugar) and arterial hypertension (increased blood pressure). The aim of this study is to evaluate whether a prune-based nutritional supplement which enhances the feeling of satiety (feeling satisfied) may help in limiting daily food consumption.
Who can participate?
Women >18 years of age without severe comorbidity and a body mass index (BMI) between ≥25 and <35. We will exclude pregnant or breast-feeding women, women with a known allergy to prunes and / or endocrine disorders (i.e., hyper- or hypothyroidism, known diseases of the ovary, the adrenal or pituitary glands).
What does the study involve?
Participants will randomly be assigned to daily intake of 40 g of a prune-base nutritional supplement (PDF4 gel), or an undistiguishable placebo (dummy) for two weeks. The protocol allows for an otherwise unrestricted diet. Clinical assessments including measurement of height and weight will be made at baseline (i.e., before allocation to one or the other intervention), after two and four weeks. Participants will be asked to fill out standardized health outcome form and a questionnaire about eating habits at baseline and after two weeks.
What are the possible benefits and risks of participating?
According to German regulations, the investigators are obliged to inform potential participants that they cannot guarantee any benefit from trial participation. The prune formulation may ease weight reduction by avoiding the feeling of hunger. Both the PDF4 gel and the placebo gel have been classified as nutritional supplements according to German federal and European laws. We do not expect specific risks for the trial participants.
Where is the study run from?
Participants will be recruited at the Spa Health Resort in Bad Ems, Germany.
When is the study starting and how long is it expected to run for?
This is a pilot trial to be commenced in August 2012. The expected recruitment period is four months. In case of a faster than forecasted enrollment, the trial will be closed after inclusion of the required 60 participants.
Who is funding the study?
The study is funded by the manufacturer, Dynamic Nutrition Lab, Miesbach, Germany, and QinDAO Research & Development, Berlin, Germany.
Who is the main contact?
Professor Dietmar Lorenz
hdl-medizin@online.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Dietmar Lorenz
ORCID ID
Contact details
Alter Postweg 6
Fachbach
56133
Germany
hdl-medizin@online.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CIP MPMG-2012-03_013
Study information
Scientific title
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
Acronym
Study hypothesis
In women with pre-obesity and obesity grade I, nutritional supplementation with PDF4 gel will lead to an average reduction in BMI of 1.5 - 2.0 kg/m2 two weeks after randomization compared to a placebo control.
Ethics approval
Ethics Commission Freiburg, Germany, 16 July 2012, ref: FEKI 012 / 1546
Study design
Placebo-controlled randomized single-center trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Moderately overweight
Intervention
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 + normal food intake
Both interventions have been classified as a nutritional supplements complying with German Federal and European regulations.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mean difference in BMI reduction between verum (PDF4 gel) and placebo gel two weeks after randomization
Secondary outcome measures
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.
Overall trial start date
01/08/2012
Overall trial end date
01/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2 x 30 balance block randomization
Participant exclusion criteria
1. BMI <25 or 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
Recruitment start date
01/08/2012
Recruitment end date
01/11/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Alter Postweg 6
Fachbach
56133
Germany
Sponsor information
Organisation
Dynamic Nutrition Lab (Germany)
Sponsor details
Marktplatz 7
Miesbach
83714
Germany
+49 8025 3029
michael.helm@dynamische-ernaehrung.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dynamic Nutrition Lab (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list