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Haalbaarheidsstudie: Onderzoek naar het effect van twee gezonde voedingspatronen op lichamelijke en psychische klachten.


- candidate number22870
- NTR NumberNTR5492
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2015
- Secondary IDsM15.177545 NL53798.042.15
- Public TitleHaalbaarheidsstudie: Onderzoek naar het effect van twee gezonde voedingspatronen op lichamelijke en psychische klachten.
- Scientific TitleHaalbaarheidsstudie: Onderzoek naar het effect van twee gezonde voedingspatronen op lichamelijke en psychische klachten.
- ACRONYMHaalbaarheidsstudie voedingspatronen
- hypothesisDifferent studies have shown that a hunter-gatherer type diet is effective in improving glucose regulation and lipid profile. I want to investigate if the hypothese that this type of diet also reduces the number of physical and psychological symptoms can be proved.
- Healt Condition(s) or Problem(s) studiedPsychological problems, Physical complaints, Diet
- Inclusion criteria- 18 years or older
- Good understanding and knowlegde of the Dutch language
- Being willing to follow both of the diets for four weeks.
- Exclusion criteria- Following a pottasium-restricted diet
- Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-sep-2015
- planned closingdate31-dec-2015
- Target number of participants35
- InterventionsEach participant will eat according to the Dutch Consensus Diet during 4 weeks and according to the Palaeolithic Diet during 4 weeks.
- Primary outcome: Four aspects of feasibility will be studied. First, the amount of time needed to recruit 35 participants. Second, the percentage of participants that completes the study. Third, the extent to which the participants followed the two diets, Fourth, representativeness of our participants for the normal population.
- Secondary outcomeEffect size on physical and psychological complaints.
- TimepointsAt t=0 a intake questionnaire will be administered.
At t=0, t=4 and and t=8 weeks a questionnaire about the physical and psychological complaints will be administered.
Every week a nutrition questionnaire will be administered.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESE. Nederhof
- CONTACT for SCIENTIFIC QUERIESE. Nederhof
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryDifferent studies have shown that a hunter-gatherer type diet is effective in improving glucose regulation an lipid profile. This research focusses on the question of this type of diet also reduces the number of physical en psychological symptoms. The main objective is to test feasibility of a cross-over study comparing the effect of two healthy diets on physical an psychological symptoms. The secondairy aim is the estimate effect size. In this cross-over designed studie, 25 individuals of 18 years or older from the normal population will be included. Each participant will eat according to the Dutch Consensus Diet during 4 weeks and according to the Palaeolithic Diet during 4 weeks. Four aspects of feasibility will be studied. First, the amount of time needed to recruit 35 participants. Second, the percentage of participants that completes the study. Third, the extent to which the participants followed the two diets, Fourth, representativeness of our participants for the normal population. Furthermore, we will estimate effect size on physical and psychological complaints.
- Main changes (audit trail)
- RECORD14-sep-2015 - 5-jan-2016


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