Clinical trial NCT02321033: Influence of Daylong Glycemia on Detraining Induced Metabolic Changes
Official title: Einfluss Der Postprandialen Glykämie Auf Inaktivitäts-induzierte Veränderungen im Stoffwechsel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: glycemic index
inactivity
insulin sensitivity
metabolic flexibility
arterial stiffness
young men
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: The duration of the study is 7 weeks: two x 2 weeks intervention (phase A and phase B) with 3 weeks washout phase inbetween. Each 2-week intervention phase consists of an active week followed by an inactive week.

in phase A subjects consume high GI (maltodextrin and sucrose) soft drinks during the inactive week. In phase B subjects consume a low GI soft drink (palatinose) during the inactive week.

subjects were randomly assigned to either start with phase A or with phase B (cross over design).

During the whole study duration all food is provided (55% CHO, 30% fat, 15% protein)

Physical activity will be assessed by a step counter (active phase 7000-10000 steps/d and inactive phase 3000-4000 steps/d).

Eligibility criteria: Inclusion Criteria:

* normal weight men,
* age 18-35 y,
* active life style,
* \> 300 min sports/week

Exclusion Criteria:

* food allergies,
* regular use of medication,
* smoking,
* chronic disease,
* vegan/vegetarian diet

Primary outcomes:
measure: Influence of GI on inactivity-induced changes in insulin sensitivity as measured by an OGTT
timeFrame: 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:
measure: Influence of GI on inactivity-induced changes in metabolic flexibility as measured by indirect calorimetry (RER, respiratory exchange ratio)
timeFrame: 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:
measure: Influence of GI on inactivity-induced changes in parameters of arterial stiffness as measured by pulse wave velocity
timeFrame: 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
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Anja Bosy-Westphal, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References: