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Building Bridges between Physical Activity and Diet to improve (cognitive) health after a meal


- candidate number28578
- NTR NumberNTR7028
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2018
- Secondary IDsNL64153.091.17/2017-4001 NL nummer/dossiernummer CMO regio Arnhem-Nijmegen
- Public TitleBuilding Bridges between Physical Activity and Diet to improve (cognitive) health after a meal
- Scientific TitleBuilding Bridges between Physical Activity and Diet to improve postprandial (cognitive) health
- ACRONYMBridgePAD
- hypothesisThe composition of a meal might influence the effect of breaking up prolonged sitting on cognition
- Healt Condition(s) or Problem(s) studiedSedentary behavior, Cognitive functions, Western diet
- Inclusion criteriaOverweight or obese (BMI ≥ 25 kg/m2 ≤ 35 kg/m2) men/women aged ≥ 45 years, who are sedentary and physically inactive.
- Exclusion criteriaDiabetes mellitus (type 1/ type 2), cardiovascular disease, untreated hypertension, castrointestinal disease, epilepsy, cancer, thyroid disease, mental disorders, food allergies/intolerances interfering with the study, physical/mental conditions interfering with the study, major illness or injury, glucose/lipid-lowering medication, anti-inflammatory medication, anti-depressants, smoking, following of a strict diet, alcohol consumption > than 3 glasses a day, pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-jan-2021
- Target number of participants24
- InterventionsParticipants report 4 times to our laboratory and will receive either a western type breakfast or a 'healthy' breakfast. After the meal, they will be exposed to four hours of continuous sitting or sitting interrupted with 5 minute bouts of moderate intensity physical activity every 30 minutes. In total, participants will be exposed to four different combinations (in a randomized order on different days) of a breakfast and sitting/physical activity, with a wash-out period of one week in between conditions.
- Primary outcomeThe primary objective is to determine whether the composition of a meal alters the impact of prolonged, uninterrupted sitting and sitting interrupted with bouts of moderate-intensity physical activity on cognitive function.
- Secondary outcomeThe secondary objective is to determine whether the composition of a meal alters the impact of prolonged, uninterrupted sitting and sitting interrupted with bouts of moderate-intensity physical activity on cerebrovascular health, metabolic health and perceivable benefits. This will give insights into possible mechanism linking nutrition and physical activity with cognition.
- TimepointsOne screenings visit.
After enrollment, four visits with a one week period in between.
- Trial web siteN.A.
- statusplanned
- CONTACT FOR PUBLIC QUERIES Lisa Wanders
- CONTACT for SCIENTIFIC QUERIES Lisa Wanders
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summaryRationale: Sedentary behaviour is an independent risk factor for cardiovascular disease, type II diabetes and all-cause mortality and might also be related to impaired cognitive function. In society today, often unhealthy meals are consumed (e.g. high fat/high calorie) followed by prolonged periods of sitting. Resultantly, people are exposed to the negative effects of sitting and of the meal. Much research has been done to determine if reducing sitting can improve metabolic health and results suggest that breaking up sitting with low-intensity or moderate physical activity can modulate cardiovascular risk factors. However, less is known about how a meal could interfere with the acute effects of sitting and/or breaking up sitting on cardiovascular and cognitive health.
Objective: The primary objective of this study is to determine whether the content of a meal alters the impact of prolonged, uninterrupted sitting and breaking up prolonged sitting on cognitive function. The secondary objective is to determine these impacts on cerebrovascular health, metabolic health and perceivable benefits to better understand possible underlying mechanisms. The tertiary objective is to explore the role of inflammation and oxidative stress in mediating the impact.
Study design: Cross-over design.
Study population: 24 overweight or obese (age ≥ 45 years, BMI ≥ 25 kg/m2 ≤ 35 kg/m2), sedentary (sitting more than 40 hours a week) men and women.
Intervention (if applicable): Participants report 4 times to our laboratory and will receive either a western type breakfast or a 'healthy' breakfast. After the meal, they will be exposed to four hours of continuous sitting or sitting interrupted with 5 minute bouts of moderate intensity physical activity every 30 minutes. In total, participants will be exposed to four different combinations (in a randomized order on different days) of a breakfast and sitting/physical activity, with a wash-out period of one week in between conditions.
Main study parameters/endpoints: The main study parameter is cognitive function, assessed as flexibility, alertness and working memory with the computerized Test of Attentional Performance (TAP). Secondary parameters are cerebrovascular health (i.e. coronary artery reactivity, brain-derived neurotrophic factor levels), metabolic health (i.e. glucose, insulin, cholesterol, triglyceride levels) and perceivable benefits (i.e. mood, satiety/hunger and sleepiness, measured with specific questionnaires). Tertiary parameters are markers for inflammation and oxidative stress.
- Main changes (audit trail)
- RECORD16-feb-2018 - 8-mrt-2018


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