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CompletedNCT02321033Updated Nov 18, 2015

Influence of Daylong Glycemia on Detraining Induced Metabolic Changes

An interventional study of soft drinks in Healthy, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-18.

Sponsored by University of Hohenheim · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Healthy

Keywords

  • glycemic index
  • inactivity
  • insulin sensitivity
  • metabolic flexibility
  • arterial stiffness
  • young men
03

In context

Sedentary Behavior

368 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.

This study's enrollment of 16 is below the median of 70 across 314 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • food allergies,
  • regular use of medication,
  • smoking,
  • chronic disease,
  • vegan/vegetarian diet
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    low glycemic index

    palatinose in soft drinks

    Dietary Supplement: soft drinks

  • Experimental
    high glycemic index

    sucrose plus maltodextrin in soft drinks

    Dietary Supplement: soft drinks

Interventions

  • Dietary supplementsoft drinks

    soft drinks with palatinose and maltodextrin

06

What researchers measure

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

    Time frame: 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)

    Impact of GI on inactivity induced changes in metabolic flexibility Metabolic flexibility is defined as the body´s ability to adapt fuel oxidation to changing fuel availability and energy demand It is measured as change in fasting RER (fasting metabolic flexibility) and change in RQ (difference between the end of high activity and low activity phases) after an oral glucose tolerance test (postprandial metabolic flexibility)

    Time frame: 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

    impact of GI on inactivity-induced changes (difference between the end of high activity and low activity phases) in arterial stiffness (as assessed by pulse wave velocity)

    Time frame: 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

07

Study locations

1 site
  • Institute of Nutritional Medicine, University of Hohenheim
    Stuttgart, 70599, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2014, a primary completion of Jun 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2014
First posted
Dec 22, 2014
Start
Aug 2014
Primary completionActual
Jun 2015
CompletionActual
Sep 2015
Last update
Nov 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02321033
Lead sponsor
University of Hohenheim
Responsible party
Sponsor
First posted
Dec 22, 2014
Start date
Aug 2014
Primary completion
Jun 2015
Completion
Sep 2015
Last update
Nov 18, 2015

Study contacts

Anja Bosy-Westphal, Prof PhD
principal investigator · University of Hohenheim, Stuttgart, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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