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CompletedNCT02827318Updated Jul 11, 2016

Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load

An interventional study of Isomaltulose and Glucose in Hunger, sponsored by Swansea University. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Swansea University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

Read the detailed description

There is growing recognition that lowering the glycaemic load of the diet might reduce a range of cardiovascular risk factors such as raised plasma triglycerides, HbA1c and C reactive protein and aid in body weight regulation. A proposed mechanism includes higher satiety and prolonged satiation by virtue of improved postprandial metabolic control, although, whether lower GL meals result in greater weight loss or increased satiety is still a matter of debate. One matter complicating the issue is that the desire to consume food may be driven by psychological factors; food reward centres in the brain may override hormonal regulation of food intake. Amongst psychological factors disinhibition has the largest and most consistent body of empirical data that associates it with weight gain although the mechanisms involved are unknown. This study will investigate whether, irrespective of BMI or habitual diet, disinhibited eaters have greater glycaemic excursions following a high glycaemic load drink and whether this predicts subsequent satiation.

02

Conditions studied

  • Hunger

Keywords

  • Blood glucose
03

In context

Lead sponsor

Swansea University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    75g glucose

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

    Dietary Supplement: Glucose

  • Experimental
    75g isomaltulose

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

    Dietary Supplement: Isomaltulose

  • Placebo comparator
    Sweetened water

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

    Dietary Supplement: Sweetened water

Interventions

  • Dietary supplementIsomaltulose

    75g Isomaltulose (low glycaemic load intervention)

  • Dietary supplementGlucose

    75g Glucose (high glycaemic load intervention)

  • Dietary supplementSweetened water

    Sweetened water will be used as a control

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to 30 minutes

  2. Change in blood glucose

    As above to assess the speed of decline.

    Time frame: from 30 to 150minutes

Secondary outcomes

  1. Hunger

    Participants were asked to respond to the question "how hungry are you feeling right now" on a single 100mm visual analogue scale anchored by "Not at all" and "Extremely".

    Time frame: 30, 150 minutes

07

Study locations

1 site
  • Swansea University
    Swansea, West Glamorgan SA2 8PP, United Kingdom
08

References and documents

Publications

  • 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. PubMed 27761024 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02827318
Lead sponsor
Swansea University
Responsible party
Dr Hayley Young (Dr, Swansea University) — Principal investigator
First posted
Jul 11, 2016
Start date
Sep 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jul 11, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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