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

Hunger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827318
• Other study ID #: DisGL
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: July 5, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hunger

Intervention

Dietary Supplement:
• Isomaltulose
75g Isomaltulose (low glycaemic load intervention)
• Glucose
75g Glucose (high glycaemic load intervention)
• Sweetened water
Sweetened water will be used as a control

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	West Glamorgan

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Change in blood glucose	As above to assess the speed of decline.	from 30 to 150minutes	Yes
Secondary	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".	30, 150 minutes	No