HungerNCT02827318
Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load
A study testing Isomaltulose, Glucose and Sweetened water in people with Hunger, run by Swansea University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hunger
- What is being tested?
- Isomaltulose, Glucose and Sweetened water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy adults who scored either high or low on the Three factor eating questionnaire disinhibition subscale
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Swansea University
Swansea, West Glamorgan, SA2 8PP
About this study
Official title: 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.
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.
- Conditions
- Hunger
- Being tested
- Isomaltulose, Glucose, Sweetened water
- Keywords
- Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseDietary supplement
75g Isomaltulose (low glycaemic load intervention)
GlucoseDietary supplement
75g Glucose (high glycaemic load intervention)
Sweetened waterDietary supplement
Sweetened water will be used as a control
| Study group | Role | What they receive |
|---|---|---|
| 75g glucose | Active comparator | 75g of glucose dissolved in 500ml provided in a clear plastic tumbler. Receives: Dietary Supplement: Glucose |
| 75g isomaltulose | Experimental | 75g of isomaltulose dissolved in 500ml provided in a clear plastic tumbler. Receives: Dietary Supplement: Isomaltulose |
| Sweetened water | Placebo comparator | 500ml water sweetened with sucralose provided in a clear plastic tumbler. Receives: Dietary Supplement: Sweetened water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 30 minutes
Change in blood glucose
As above to assess the speed of decline.
Measured: 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".
Measured: 30, 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HungerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hayley Young, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827318
- Sponsor's protocol ID
- DisGL
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disinhibition and Vagal Tone Moderate the Postprandial Response to Glycaemic Load: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02827318
- Acronym / sponsor ID
- DisGL
- Conditions
- Hunger
- Keywords
- Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 75g glucose | Active comparator | Dietary Supplement: Glucose75g of glucose dissolved in 500ml provided in a clear plastic tumbler. |
| 75g isomaltulose | Experimental | Dietary Supplement: Isomaltulose75g of isomaltulose dissolved in 500ml provided in a clear plastic tumbler. |
| Sweetened water | Placebo comparator | Dietary Supplement: Sweetened water500ml water sweetened with sucralose provided in a clear plastic tumbler. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young healthy adults who scored either high or low on the Three factor eating questionnaire disinhibition subscale
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isomaltulose75g Isomaltulose (low glycaemic load intervention) | Dietary supplement | 75g isomaltulose |
| Glucose75g Glucose (high glycaemic load intervention) | Dietary supplement | 75g glucose |
| Sweetened waterSweetened water will be used as a control | Dietary supplement | Sweetened water |
Primary outcome
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.
Change in blood glucose
Time frame: from 30 to 150minutes
As above to assess the speed of decline.
1 secondary outcome
Hunger
Time frame: 30, 150 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Derived from this study: PubMed 27761024Young 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.
Related trials for Hunger
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Active, not recruiting
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation
Recruiting
Assessing the Relationships Between Parent-child Eating in the Absence of Hunger, Appetitive Traits, and Food Parenting.
Eating in Absence of Hunger, Food Parenting
Recruiting
Evaluation of the Effectiveness of Nutritional Supplement Packages on Improving School Children's Hunger, Eating Behavior and Classroom Concentration
Classroom Concentration, Dietary Diversity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltulose, Glucose and Sweetened water in people with Hunger, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose (time frame: From baseline to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.