NCT02960373

Brief Summary

Dried fruits show promising potential for the management of blood glucose. Previous trials have reported beneficial effects of raisins on post-prandial glucose and insulin responses in healthy individuals when compared with white bread. However, to date there is limited data evaluating the potential beneficial effects of other dried fruits (i.e. sultanas, dates and apricots). It is also unclear whether dried fruits can be used to lower the postprandial glycemic responses to high-GI carbohydrate foods by either displacing available carbohydrate (displacement effect) or providing 'catalytic' doses of fructose ('catalytic' fructose effect). To address these questions, the investigators propose to assess the GI of 4 common types of dried fruit (raisins, sultanas, dates, apricots) (GI effect) and their ability to decrease the postprandial glycemic response to white bread by either partially displacing available carbohydrate (displacement effect) or by providing a 'catalytic' dose of fructose ('catalytic' fructose effect).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

November 1, 2016

Last Update Submit

November 7, 2016

Conditions

PreDiabetesDiabetes MellitusDysglycemia

Keywords

Dried fruitGlycemic IndexCatalytic doseGlycemic responseFructosePostprandialRandomized clinical trialCarbohydrate metabolism

Outcome Measures

Primary Outcomes (1)

  • Glycemic index (GI)

    Up to 120min

Study Arms (4)

White Bread (Control)

ACTIVE COMPARATOR

Participants will consume a test meal containing white bread (dose: 50g available carbohydrate) at three study visits.

Other: White Bread (Control)

Dried Fruit - Glycemic Index

EXPERIMENTAL

Participants will consume a test meal containing one variety of dried fruit (dose: 50g available carbohydrate) per visit for four visits. Varieties include raisins, sultanas, dates, and apricots.

Other: Dried Fruit - Glycemic Index

Catalytic Fructose Dose Effect

EXPERIMENTAL

Participants will consume a test meal containing white bread (dose: 50g available carbohydrate) and one variety of dried fruit (dose: 7g fructose) per visit for four visits. Varieties of dried fruit include: raisins, sultanas, dates, and apricots.

Other: Catalytic Fructose Dose Effect

High GI Displacement Effect

EXPERIMENTAL

Participants will consume a test meal containing white bread (dose: 25g available carbohydrate) and one variety of dried fruit (dose: 25g available carbohydrate) per visit for four visits. Varieties of dried fruit include: raisins, sultanas, dates, and apricots.

Other: High GI Displacement Effect

Interventions

White Bread (Control)OTHER

A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.

White Bread (Control)
Dried Fruit - Glycemic IndexOTHER

A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.

Dried Fruit - Glycemic Index
Catalytic Fructose Dose EffectOTHER

A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.

Catalytic Fructose Dose Effect
High GI Displacement EffectOTHER

A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.

High GI Displacement Effect

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males and/or non-pregnant females aged 18-75 years and in good health

You may not qualify if:

  • Age less than 18 years or greater than 75 years
  • BMI\<18.5kg/m2 or \>30kg/m2
  • Known history of HIV, liver disease, kidney disease, thyroid disease, diabetes, heart disease or or any other major illnesses that may affect carbohydrate metabolism
  • Subjects using medications which might, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
  • Subjects who cannot or will not comply with the experimental procedures or do not follow the clinic's safety guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Labs

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (19)

  • Esfahani A, Lam J, Kendall CW. Acute effects of raisin consumption on glucose and insulin reponses in healthy individuals. J Nutr Sci. 2014 Jan 7;3:e1. doi: 10.1017/jns.2013.33. eCollection 2014.

    PMID: 25191601BACKGROUND

  • University of Sydney, Online Glycemic Index Database. Accessed December 02 2015. URL Www.glycemicindex.com n.d.

    BACKGROUND

  • Kendall CW, Josse AR, Esfahani A, Jenkins DJ. The impact of pistachio intake alone or in combination with high-carbohydrate foods on post-prandial glycemia. Eur J Clin Nutr. 2011 Jun;65(6):696-702. doi: 10.1038/ejcn.2011.12. Epub 2011 Mar 2.

    PMID: 21364607BACKGROUND

  • Kim Y, Hertzler SR, Byrne HK, Mattern CO. Raisins are a low to moderate glycemic index food with a correspondingly low insulin index. Nutr Res. 2008 May;28(5):304-8. doi: 10.1016/j.nutres.2008.02.015.

    PMID: 19083424BACKGROUND

  • Agius L, Peak M. Intracellular binding of glucokinase in hepatocytes and translocation by glucose, fructose and insulin. Biochem J. 1993 Dec 15;296 ( Pt 3)(Pt 3):785-96. doi: 10.1042/bj2960785.

    PMID: 8280078BACKGROUND

  • Van Schaftingen E, Detheux M, Veiga da Cunha M. Short-term control of glucokinase activity: role of a regulatory protein. FASEB J. 1994 Apr 1;8(6):414-9. doi: 10.1096/fasebj.8.6.8168691.

    PMID: 8168691BACKGROUND

  • Detheux M, Vandercammen A, Van Schaftingen E. Effectors of the regulatory protein acting on liver glucokinase: a kinetic investigation. Eur J Biochem. 1991 Sep 1;200(2):553-61. doi: 10.1111/j.1432-1033.1991.tb16218.x.

    PMID: 1889418BACKGROUND

  • Vandercammen A, Detheux M, Van Schaftingen E. Binding of sorbitol 6-phosphate and of fructose 1-phosphate to the regulatory protein of liver glucokinase. Biochem J. 1992 Aug 15;286 ( Pt 1)(Pt 1):253-6. doi: 10.1042/bj2860253.

    PMID: 1520277BACKGROUND

  • Hawkins M, Gabriely I, Wozniak R, Vilcu C, Shamoon H, Rossetti L. Fructose improves the ability of hyperglycemia per se to regulate glucose production in type 2 diabetes. Diabetes. 2002 Mar;51(3):606-14. doi: 10.2337/diabetes.51.3.606.

    PMID: 11872657BACKGROUND

  • Petersen KF, Laurent D, Yu C, Cline GW, Shulman GI. Stimulating effects of low-dose fructose on insulin-stimulated hepatic glycogen synthesis in humans. Diabetes. 2001 Jun;50(6):1263-8. doi: 10.2337/diabetes.50.6.1263.

    PMID: 11375325BACKGROUND

  • Moore MC, Cherrington AD, Mann SL, Davis SN. Acute fructose administration decreases the glycemic response to an oral glucose tolerance test in normal adults. J Clin Endocrinol Metab. 2000 Dec;85(12):4515-9. doi: 10.1210/jcem.85.12.7053.

    PMID: 11134101BACKGROUND

  • Heacock PM, Hertzler SR, Wolf BW. Fructose prefeeding reduces the glycemic response to a high-glycemic index, starchy food in humans. J Nutr. 2002 Sep;132(9):2601-4. doi: 10.1093/jn/132.9.2601.

    PMID: 12221216BACKGROUND

  • Iida T, Kishimoto Y, Yoshikawa Y, Hayashi N, Okuma K, Tohi M, Yagi K, Matsuo T, Izumori K. Acute D-psicose administration decreases the glycemic responses to an oral maltodextrin tolerance test in normal adults. J Nutr Sci Vitaminol (Tokyo). 2008 Dec;54(6):511-4. doi: 10.3177/jnsv.54.511.

    PMID: 19155592BACKGROUND

  • Hayashi N, Iida T, Yamada T, Okuma K, Takehara I, Yamamoto T, Yamada K, Tokuda M. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects. Biosci Biotechnol Biochem. 2010;74(3):510-9. doi: 10.1271/bbb.90707. Epub 2010 Mar 7.

    PMID: 20208358BACKGROUND

  • Moore MC, Davis SN, Mann SL, Cherrington AD. Acute fructose administration improves oral glucose tolerance in adults with type 2 diabetes. Diabetes Care. 2001 Nov;24(11):1882-7. doi: 10.2337/diacare.24.11.1882.

    PMID: 11679451BACKGROUND

  • Sievenpiper JL, Chiavaroli L, de Souza RJ, Mirrahimi A, Cozma AI, Ha V, Wang DD, Yu ME, Carleton AJ, Beyene J, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Kendall CW, Jenkins DJ. 'Catalytic' doses of fructose may benefit glycaemic control without harming cardiometabolic risk factors: a small meta-analysis of randomised controlled feeding trials. Br J Nutr. 2012 Aug;108(3):418-23. doi: 10.1017/S000711451200013X. Epub 2012 Feb 21.

    PMID: 22354959BACKGROUND

  • Cozma AI, Sievenpiper JL, de Souza RJ, Chiavaroli L, Ha V, Wang DD, Mirrahimi A, Yu ME, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TM, Beyene J, Kendall CW, Jenkins DJ. Effect of fructose on glycemic control in diabetes: a systematic review and meta-analysis of controlled feeding trials. Diabetes Care. 2012 Jul;35(7):1611-20. doi: 10.2337/dc12-0073.

    PMID: 22723585BACKGROUND

  • Guidance for Industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (DRAFT GUIDANCE), U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Editor. 2008: Rockville, MD. p. 1-30.

    BACKGROUND

  • Viguiliouk E, Jenkins AL, Blanco Mejia S, Sievenpiper JL, Kendall CWC. Effect of dried fruit on postprandial glycemia: a randomized acute-feeding trial. Nutr Diabetes. 2018 Dec 11;8(1):59. doi: 10.1038/s41387-018-0066-5.

    PMID: 30531821DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John L Sievenpiper, MD PhD FRCPC

    University of Toronto, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

  • Cyril Kendall, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Effie Viguiliouk, MSc

CONTACT

416-867-7460effie.viguiliouk@mail.utoronto.ca

Rebecca Noseworthy, MPH, RD

CONTACT

416-867-7460rebecca.noseworthy@utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Staff Physician, Scientist

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 9, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

CA(1)