NCT02321033

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

August 21, 2014

Last Update Submit

November 17, 2015

Conditions

Keywords

glycemic indexinactivityinsulin sensitivitymetabolic flexibilityarterial stiffnessyoung men

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

EXPERIMENTAL

palatinose in soft drinks

Dietary Supplement: soft drinks

high glycemic index

EXPERIMENTAL

sucrose plus maltodextrin in soft drinks

Dietary Supplement: soft drinks

Interventions

soft drinksDIETARY_SUPPLEMENT

soft drinks with palatinose and maltodextrin

high glycemic indexlow glycemic index

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Sedentary BehaviorInsulin Resistance

Interventions

Carbonated Beverages

Condition Hierarchy (Ancestors)

BehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Anja Bosy-Westphal, Prof PhD

    University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

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

Locations