Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/07/2012
Date assigned
02/08/2012
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes