Influence of Daylong Glycemia on Detraining Induced Metabolic Changes
Einfluss Der Postprandialen Glykämie Auf Inaktivitäts-induzierte Veränderungen im Stoffwechsel
1 other identifier
interventional
16
1 country
1
Brief Summary
Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to detraining. The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Aug 2014
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 18, 2015
November 1, 2015
10 months
August 21, 2014
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Influence of GI on inactivity-induced changes in insulin sensitivity as measured by an OGTT
Influence of GI (glycemic index) on detraining-induced changes (difference between the end of high activity and low activity phases) in insulin sensitivity Insulin sensitivity is assessed by HOMA and Matsuda indices
the difference between the end of each 1 week activity phase (day 7 vs. day 14, low vs. high physical activity) is compared between high GI and low GI intervention
Secondary Outcomes (1)
Influence of GI on inactivity-induced changes in metabolic flexibility as measured by indirect calorimetry (RER, respiratory exchange ratio)
the difference between the end of each 1 week activity phase (day 7 vs. day 14) is compared between high GI and low GI intervention
Other Outcomes (1)
Influence of GI on inactivity-induced changes in parameters of arterial stiffness as measured by pulse wave velocity
the difference between the end of each 1 week activity phase (day 7 vs. day 14) is compared between high GI and low GI intervention
Study Arms (2)
low glycemic index
EXPERIMENTALpalatinose in soft drinks
high glycemic index
EXPERIMENTALsucrose plus maltodextrin in soft drinks
Interventions
soft drinks with palatinose and maltodextrin
Eligibility Criteria
You may qualify if:
- normal weight men,
- age 18-35 y,
- active life style,
- \> 300 min sports/week
You may not qualify if:
- food allergies,
- regular use of medication,
- smoking,
- chronic disease,
- vegan/vegetarian diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anja Bosy-Westphal, Prof PhD
University of Hohenheim, Stuttgart, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2014
First Posted
December 22, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
November 18, 2015
Record last verified: 2015-11