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Completed

NCT Number: NCT02974478

Orange Juice Consumption and Glucose Metabolism and Antioxidative Status

Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

About this study

Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.

During wash-out weeks consumption of orange juice or citrus fruits is restricted.

During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy

Exclusion criteria

  • regular use of medication,
  • smoking,
  • chronic disease,
  • vegan/vegetarian diet,
  • fructose intolerance,
  • irregular eating behaviour (less then 3 meals/day)

Treatment and study plan

Orange juice with meals

Dietary Supplement

orange juice (20% of energy requirement/day)

Orange juice between meals

Dietary Supplement

orange juice (20% of energy requirement/day)

Sugar sweetened beverage between meals

Dietary Supplement

Sugar sweetened beverage (20% of energy requirement/day)

Primary outcomes

  1. changes in daylong glycaemia between pre and post intervention periods

    Time frame: two weeks

    measured via continuous glucose monitoring [mg/dL]

Secondary outcomes

  1. changes in uric acid between pre and post intervention periods

    Time frame: two weeks

    measured via uric acid serum levels [mg/dL]

  2. changes in insulin sensitivity between pre and post intervention periods

    Time frame: two weeks

    measured via "Matsuda-Index" from oral glucose tolerance test data

  3. changes in antioxidative status between pre and post intervention periods

    Time frame: two weeks

    measured via vitamin c blood levels [mg/L]

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 28, 2016
Registry last updated
Apr 25, 2017

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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