Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load
1 other identifier
interventional
66
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedJuly 11, 2016
July 1, 2016
3 months
June 29, 2016
July 5, 2016
Conditions
Keywords
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 COMPARATOR75g of glucose dissolved in 500ml provided in a clear plastic tumbler.
75g isomaltulose
EXPERIMENTAL75g of isomaltulose dissolved in 500ml provided in a clear plastic tumbler.
Sweetened water
PLACEBO COMPARATOR500ml water sweetened with sucralose provided in a clear plastic tumbler.
Interventions
Eligibility Criteria
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
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.
PMID: 27761024DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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