HealthyNCT02321033
Influence of Daylong Glycemia on Detraining Induced Metabolic Changes
A study testing soft drinks in people with Healthy, run by University of Hohenheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- soft drinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal weight men,
- age 18-35 y,
- active life style,
- > 300 min sports/week
Who cannot join
- food allergies,
- regular use of medication,
- smoking,
- chronic disease,
- vegan/vegetarian diet
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
About this study
Official title: Einfluss Der Postprandialen Glykämie Auf Inaktivitäts-induzierte Veränderungen im Stoffwechsel
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).
- Conditions
- Healthy
- Being tested
- soft drinks
- Keywords
- glycemic index, inactivity, insulin sensitivity, metabolic flexibility, arterial stiffness, young men
- Medical subject headings
- Sedentary Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft drinksDietary supplement
soft drinks with palatinose and maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| low glycemic index | Experimental | palatinose in soft drinks Receives: Dietary Supplement: soft drinks |
| high glycemic index | Experimental | sucrose plus maltodextrin in soft drinks Receives: Dietary Supplement: soft drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Bosy-Westphal, Prof PhD, Principal investigator, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321033
- Sponsor's protocol ID
- Lazysportsmen2014
- Status last verified
- Nov 2015
- First submitted
- 21 Aug 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Der Postprandialen Glykämie Auf Inaktivitäts-induzierte Veränderungen im Stoffwechsel
- ClinicalTrials.gov ID
- NCT02321033
- Acronym / sponsor ID
- Lazysportsmen2014
- Conditions
- Healthy
- Keywords
- glycemic index, inactivity, insulin sensitivity, metabolic flexibility, arterial stiffness, young men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low glycemic index | Experimental | Dietary Supplement: soft drinkspalatinose in soft drinks |
| high glycemic index | Experimental | Dietary Supplement: soft drinkssucrose plus maltodextrin in soft drinks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal weight men,
- age 18-35 y,
- active life style,
- > 300 min sports/week
Key exclusion criteria (5 listed)
- food allergies,
- regular use of medication,
- smoking,
- chronic disease,
- vegan/vegetarian diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft drinkssoft drinks with palatinose and maltodextrin | Dietary supplement | high glycemic index, low glycemic index |
Primary outcome
Influence of GI on inactivity-induced changes in insulin sensitivity as measured by an OGTT
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
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
1 secondary outcome
Influence of GI on inactivity-induced changes in metabolic flexibility as measured by indirect calorimetry (RER, respiratory exchange ratio)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Bosy-Westphal, Prof PhD principal investigator
University of Hohenheim, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft drinks in people with Healthy, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of GI on inactivity-induced changes in insulin sensitivity as measured by an OGTT (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.