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Completed

NCT Number: NCT02827318

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, West Glamorgan, SA2 8PP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

isomaltulose

Dietary Supplement

75g Isomaltulose (low glycaemic load intervention)

Glucose

Dietary Supplement

75g Glucose (high glycaemic load intervention)

Sweetened water

Dietary Supplement

Sweetened water will be used as a control

Primary outcomes

  1. Change in blood glucose

    Time frame: From baseline to 30 minutes

    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.

  2. Change in blood glucose

    Time frame: from 30 to 150minutes

    As above to assess the speed of decline.

Secondary outcomes

  1. Hunger

    Time frame: 30, 150 minutes

    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".

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Registry information

Official study title

Eating Disinhibition and Vagal Tone Moderate the Postprandial Response to Glycaemic Load: A Randomised Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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