- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827318
Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load
July 5, 2016 updated by: Dr Hayley Young, Swansea University
Eating Disinhibition and Vagal Tone Moderate the Postprandial Response to Glycaemic Load: A Randomised Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Glamorgan
-
Swansea, West Glamorgan, United Kingdom, SA2 8PP
- Swansea University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 75g glucose
75g of glucose dissolved in 500ml provided in a clear plastic tumbler.
|
75g Glucose (high glycaemic load intervention)
|
EXPERIMENTAL: 75g isomaltulose
75g of isomaltulose dissolved in 500ml provided in a clear plastic tumbler.
|
75g Isomaltulose (low glycaemic load intervention)
|
PLACEBO_COMPARATOR: Sweetened water
500ml water sweetened with sucralose provided in a clear plastic tumbler.
|
Sweetened water will be used as a control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From baseline to 30 minutes
|
Change in blood glucose
Time Frame: from 30 to 150minutes
|
As above to assess the speed of decline.
|
from 30 to 150minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
30, 150 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
July 5, 2016
First Posted (ESTIMATE)
July 11, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
July 11, 2016
Last Update Submitted That Met QC Criteria
July 5, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DisGL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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