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Completed

NCT Number: NCT02321033

Influence of Daylong Glycemia on Detraining Induced Metabolic Changes

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.

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Key information

Conditions

Healthy Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Sedentary Behavior

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soft drinks

Dietary Supplement

soft drinks with palatinose and maltodextrin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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)

Other outcomes

  1. Influence of GI on inactivity-induced changes in parameters of arterial stiffness as measured 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

    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)

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

Einfluss Der Postprandialen Glykämie Auf Inaktivitäts-induzierte Veränderungen im Stoffwechsel

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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