Glycemic Response to Two Doses of Low Sugar Apple Juice
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Prediabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: a double-blind randomised controlled cross-over trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The test products (verum and control) are similar in flavour, color, texture, appearance and identical in packaging to ensure the double-blind, controlled design of the study.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption...
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice. The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
Tracking Information
- NCT #
- NCT04747639
- Collaborators
- Nofima
- Investigators
- Principal Investigator: Christiane Laue, Dr. (MD) CRC Clinical Research Center Kiel
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