NCT02827318

Brief Summary

Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for overconsumption, is characterized by reduced prefrontal cortex activity, which in turn directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and insulin levels. This double blind randomised controlled trial explores the influence of disinhibited eating and vagal tone (heart rate variability) on the postprandial response to GL and hunger.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

June 29, 2016

Last Update Submit

July 5, 2016

Conditions

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (2)

  • Change in blood glucose

    Blood glucose was monitored from finger pricks using an ExacTech sensor (Medisense Britain Limited) that using an enzymic method, coupled with microelectronic measurement. Change in blood glucose from baseline to after 30 minutes will assess the speed of incline.

    From baseline to 30 minutes

  • Change in blood glucose

    As above to assess the speed of decline.

    from 30 to 150minutes

Secondary Outcomes (1)

  • Hunger

    30, 150 minutes

Study Arms (3)

75g glucose

ACTIVE COMPARATOR

75g of glucose dissolved in 500ml provided in a clear plastic tumbler.

Dietary Supplement: Glucose

75g isomaltulose

EXPERIMENTAL

75g of isomaltulose dissolved in 500ml provided in a clear plastic tumbler.

Dietary Supplement: Isomaltulose

Sweetened water

PLACEBO COMPARATOR

500ml water sweetened with sucralose provided in a clear plastic tumbler.

Dietary Supplement: Sweetened water

Interventions

IsomaltuloseDIETARY_SUPPLEMENT

75g Isomaltulose (low glycaemic load intervention)

75g isomaltulose
GlucoseDIETARY_SUPPLEMENT

75g Glucose (high glycaemic load intervention)

75g glucose
Sweetened waterDIETARY_SUPPLEMENT

Sweetened water will be used as a control

Sweetened water

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy adults who scored either high or low on the Three factor eating questionnaire disinhibition subscale

You may not qualify if:

  • Participants were excluded if they
  • had a cardiovascular or metabolic disorder
  • gastrointestinal problems
  • were pregnant
  • had a current diagnosis of a mood or eating disorder
  • and/or were taking medications or herbal supplements to manage body weight or control appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, West Glamorgan, SA2 8PP, United Kingdom

Location

Related Publications (1)

  • Young HA, Watkins H. Eating disinhibition and vagal tone moderate the postprandial response to glycemic load: a randomised controlled trial. Sci Rep. 2016 Oct 20;6:35740. doi: 10.1038/srep35740.

MeSH Terms

Interventions

isomaltuloseGlucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 11, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations