ObesityNCT02744001
The Reinforcing Value of Added Sugars
A study testing Low Added Sugar Diet in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine how daily diet relates to eating choices. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low Added Sugar Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 16 Jan 2018
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI within 18.5-24.9 kg/m2 or BMI within 30.0-50.0 kg/m2
- Willing to consent to study conditions
- Habitually consume at least 10% of daily energy intake from added sugars
Who cannot join
- BMI 25.0-29.9 kg/m2
- Currently taking drugs that change hunger
- Have an eating disorder
- Current tobacco user
- Have diabetes or heart disease
- Pregnant, lactating or planning pregnancy
- Low liking of all available study test foods
- Allergy/aversion to any of the foods provided during the diet intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Diet Study: The Reinforcing Value of Added Sugars
The purpose of this study is to determine how daily diet relates to eating choices.
Read the detailed description
Despite the long-term emphasis on reducing intake of and added sugar, this behavioral change has been hard to instill amongst most of the population. Foods with added sugars are highly reinforcing and, as such, reducing their consumption in order to adhere to the dietary guidelines (DGA) may be difficult to maintain. Sugar produces effects similar to some drugs of abuse such as increased extracellular dopamine release in the nucleus accumbens shell resulting in a reinforcing effect. Reducing any reinforcing behavior can be challenging, but in terms of food, it is not known whether the reinforcing value of foods high in added sugar increases when access to these foods is reduced. If so, this would present a mechanistic barrier to meeting the DGA and making dietary changes in general. That the reinforcing value of a behavior (e.g., eating sugar) will be increased when the rate of that behavior is decreased has strong theoretical underpinnings in the "Disequilibrium Approach". This theory predicts that the circumstances of reinforcement are created or limited by changing baseline access. According to the Disequilibrium Approach, a response deficit will result in an increase in reinforcement. Applied to the proposed study, the Disequilibrium Approach would predict that lowering the consumption of dietary added sugar would increase the reinforcing value of foods high in added sugar. The Disequilibrium Approach has accurately predicted an increase in the relative reinforcing value (RRV) of snack foods among children. However, dietary changes would need to occur at the whole diet level for adults and children to meet the DGA for reducing added sugar intake. It is important to know if reducing added sugars at the whole-diet level results in increases in the reinforcing value of foods high in added sugars.
- Conditions
- Obesity
- Being tested
- Low Added Sugar Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Added Sugar DietOther
1-week intake of Low Added Sugar Diet 3 day rotating menu
| Study group | Role | What they receive |
|---|---|---|
| Low Added Sugar Diet | Experimental | Menu containing <10% of total daily energy intake from added sugars. Receives: Other: Low Added Sugar Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative reinforcing value (RRV) of snacks as assessed by indicator
RRV of snacks will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to a high added sugar snack or low added sugar alternative.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
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 ObesityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744001
- Sponsor's protocol ID
- GFHNRC148
- Status last verified
- Jan 2022
- First submitted
- 15 Apr 2016
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Flack KD, Ufholz K, Casperson S, Jahns L, Johnson L, Roemmich JN. Decreasing the Consumption of Foods with Sugar Increases Their Reinforcing Value: A Potential Barrier for Dietary Behavior Change. J Acad Nutr Diet. 2019 Jul;119(7):1099-1108. doi: 10.1016/j.jand.2018.12.016. Epub 2019 Apr 6.
PubMed 30962120
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Study: The Reinforcing Value of Added Sugars
- ClinicalTrials.gov ID
- NCT02744001
- Acronym / sponsor ID
- GFHNRC148
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Apr 2016 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 19 Apr 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.
The purpose of this study is to determine how daily diet relates to eating choices.
Detailed description
Despite the long-term emphasis on reducing intake of and added sugar, this behavioral change has been hard to instill amongst most of the population. Foods with added sugars are highly reinforcing and, as such, reducing their consumption in order to adhere to the dietary guidelines (DGA) may be difficult to maintain. Sugar produces effects similar to some drugs of abuse such as increased extracellular dopamine release in the nucleus accumbens shell resulting in a reinforcing effect. Reducing any reinforcing behavior can be challenging, but in terms of food, it is not known whether the reinforcing value of foods high in added sugar increases when access to these foods is reduced. If so, this would present a mechanistic barrier to meeting the DGA and making dietary changes in general. That the reinforcing value of a behavior (e.g., eating sugar) will be increased when the rate of that behavior is decreased has strong theoretical underpinnings in the "Disequilibrium Approach". This theory predicts that the circumstances of reinforcement are created or limited by changing baseline access. According to the Disequilibrium Approach, a response deficit will result in an increase in reinforcement. Applied to the proposed study, the Disequilibrium Approach would predict that lowering the consumption of dietary added sugar would increase the reinforcing value of foods high in added sugar. The Disequilibrium Approach has accurately predicted an increase in the relative reinforcing value (RRV) of snack foods among children. However, dietary changes would need to occur at the whole diet level for adults and children to meet the DGA for reducing added sugar intake. It is important to know if reducing added sugars at the whole-diet level results in increases in the reinforcing value of foods high in added sugars.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Added Sugar Diet | Experimental | Other: Low Added Sugar DietMenu containing <10% of total daily energy intake from added sugars. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI within 18.5-24.9 kg/m2 or BMI within 30.0-50.0 kg/m2
- Willing to consent to study conditions
- Habitually consume at least 10% of daily energy intake from added sugars
Key exclusion criteria (8 listed)
- BMI 25.0-29.9 kg/m2
- Currently taking drugs that change hunger
- Have an eating disorder
- Current tobacco user
- Have diabetes or heart disease
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 |
|---|---|---|
| Low Added Sugar Diet1-week intake of Low Added Sugar Diet 3 day rotating menu | Other | Low Added Sugar Diet |
Primary outcome
Change in relative reinforcing value (RRV) of snacks as assessed by indicator
Time frame: Baseline and 1 week
RRV of snacks will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to a high added sugar snack or low added sugar alternative.
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 2 Feb 2022.
- Derived from this study: PubMed 30962120Flack KD, Ufholz K, Casperson S, Jahns L, Johnson L, Roemmich JN. Decreasing the Consumption of Foods with Sugar Increases Their Reinforcing Value: A Potential Barrier for Dietary Behavior Change. J Acad Nutr Diet. 2019 Jul;119(7):1099-1108. doi: 10.1016/j.jand.2018.12.016. Epub 2019 Apr 6.
- Individual participant dataSharing planned: No
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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.
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Added Sugar Diet in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
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 3 inclusion and 8 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 2 Feb 2022. 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 States. 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. 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 relative reinforcing value (RRV) of snacks as assessed by indicator (time frame: Baseline and 1 week). 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 NCT02744001, 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 2 Feb 2022.