NCT02974478

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

November 2, 2016

Last Update Submit

April 22, 2017

Conditions

Healthy

Keywords

orange juice consumptionglucose homeostasisantioxidative status

Outcome Measures

Primary Outcomes (1)

  • changes in daylong glycaemia between pre and post intervention periods

    measured via continuous glucose monitoring \[mg/dL\]

    two weeks

Secondary Outcomes (3)

  • changes in uric acid between pre and post intervention periods

    two weeks

  • changes in insulin sensitivity between pre and post intervention periods

    two weeks

  • changes in antioxidative status between pre and post intervention periods

    two weeks

Study Arms (3)

Orange juice with meals

EXPERIMENTAL

Effect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status

Dietary Supplement: Orange juice with meals

Orange juice between meals

EXPERIMENTAL

Effect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status

Dietary Supplement: Orange juice between meals

Sugar sweetened beverage between meals

EXPERIMENTAL

Effect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status

Dietary Supplement: Sugar sweetened beverage between meals

Interventions

Orange juice with mealsDIETARY_SUPPLEMENT

orange juice (20% of energy requirement/day)

Orange juice with meals
Orange juice between mealsDIETARY_SUPPLEMENT

orange juice (20% of energy requirement/day)

Orange juice between meals
Sugar sweetened beverage between mealsDIETARY_SUPPLEMENT

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

Sugar sweetened beverage between meals

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

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

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

Interventions

Meals

Intervention Hierarchy (Ancestors)

FoodDiet, 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
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 28, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)