Sweetness Liking AdaptationNCT04284462
Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
A study testing Flavored carbonated soft drink (CSD) in people with Sweetness Liking Adaptation, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sweetness Liking Adaptation
- What is being tested?
- Flavored carbonated soft drink (CSD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 11 Mar 2020
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 25-55 years of age
- Habitually consume regular or diet carbonated soft drinks (CSD)
- Willing and able to consume at least one CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
- Willing and able to complete questionnaires regarding dietary intake and sensory perception
- Has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete daily online questionnaires.
- Participant is judged to be in good health on the basis of medical history and the general health and lifestyle questionnaire.
- Participant is willing to maintain his or her habitual diet, smoking habits and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
Who cannot join
- Regular smoker (more than 1 cigarette per week)
- History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
- Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
- Extreme changes to physical activity
- Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Recent history (within 12 months of screening; Visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
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- Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the participant at undue risk.
- Dislike of study product taste
- Participation in another clinical trial within past 30 days and participation in a PepsiCo clinical trial in the past 6 months.
- People who have phenylketonuria (low calorie sweetened beverages contain aspartame)
Trial locations and contacts
1 site in 1 country.
United States1 site
BioFortis Innovation Services
Addison, Illinois, 60101
About this study
This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):
- Intervention 1: Control (full sweetness) beverage
- Intervention 2: Step-wise sweetness reduction series of beverages
- Intervention 3: Moderate sweetness (reduced sweetness) beverage
Read more
The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.
The secondary outcome will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.
- Conditions
- Sweetness Liking Adaptation
- Being tested
- Flavored carbonated soft drink (CSD)
- Keywords
- sweetness, liking, adaptation, intensity, low calorie sweetener, full sugar, carbonated soft drink, sensory, taste, dietary compensation, beverage, perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored carbonated soft drink (CSD)Other
1-2 cans/day (330 ml per can)
| Study group | Role | What they receive |
|---|---|---|
| Control beverage for Habitual full-calorie CSD cohort, n=28 | Placebo comparator | Full sweetness (sugar) for 6 months Receives: Other: Flavored carbonated soft drink (CSD) |
| Control beverage for Habitual low-calorie CSD cohort, n=28 | Placebo comparator | Full sweetness low calorie sweetener (LCS) with sweetness level matched to the full sweetness sugar control for 6 months Receives: Other: Flavored carbonated soft drink (CSD) |
| Test beverage 1 for Habitual full-calorie CSD cohort, n=28 | Active comparator | Reduced sweetness (moderate sugar level) for 6 months Receives: Other: Flavored carbonated soft drink (CSD) |
| Test beverage 1 for Habitual low-calorie CSD cohort, n=28 | Active comparator | Reduced sweetness low calorie sweetener (LCS) with sweetness level matched to the moderate sugar sweetness level for 6 months Receives: Other: Flavored carbonated soft drink (CSD) |
| Test beverage 2 for Habitual full-calorie CSD cohort, n=28 | Active comparator | Step-wise sweetness reduction over 6 months. Month 1 is the full sweetness sugar control, followed by monthly sweetness reduction. Remains at the reduced sweetness level (moderate sugar level) from months 4-6. Receives: Other: Flavored carbonated soft drink (CSD) |
| Test beverage 2 for Habitual low-calorie CSD cohort, n=28 | Active comparator | Step-wise sweetness reduction over 6 months. Month 1 is the low calorie sweetener (LCS) sweetness equivalent of the full sweetness sugar control, followed by monthly LCS sweetness reduction (reductions equivalent to the corresponding sugar reduction arm sweetness levels). Remains at the reduced sweetness level (LCS equivalent of moderate sugar sweetness level) from months 4-6. Receives: Other: Flavored carbonated soft drink (CSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweetness liking
Likert scale, 9 point scale from 1=Dislike extremely to 9=Like extremely
Measured: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Sweetness intensity perception
Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness
Measured: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Secondary outcomes (1)
Dietary compensation for sweetness
3-day diet record to assess calories and intake of total sugar, added sugar, low-/non-calorie sweeteners
Measured: Assessed pre-intervention, then monthly x 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start14 Jan 2020
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Why it stopped: Sponsor decision to stop study due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sweetness Liking AdaptationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Kelley, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284462
- Sponsor's protocol ID
- PEP-1908
- Status last verified
- Jun 2020
- First submitted
- 19 Feb 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
- ClinicalTrials.gov ID
- NCT04284462
- Acronym / sponsor ID
- PEP-1908
- Conditions
- Sweetness Liking Adaptation
- Keywords
- sweetness, liking, adaptation, intensity, low calorie sweetener, full sugar, carbonated soft drink, sensory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to stop study due to COVID-19 pandemic
- Enrolment
- 170 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 25 Feb 2020 (actual)
- 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.
This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):
- Intervention 1: Control (full sweetness) beverage
- Intervention 2: Step-wise sweetness reduction series of beverages
- Intervention 3: Moderate sweetness (reduced sweetness) beverage
The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.
The secondary outcome will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control beverage for Habitual full-calorie CSD cohort, n=28 | Placebo comparator | Other: Flavored carbonated soft drink (CSD)Full sweetness (sugar) for 6 months |
| Control beverage for Habitual low-calorie CSD cohort, n=28 | Placebo comparator | Other: Flavored carbonated soft drink (CSD)Full sweetness low calorie sweetener (LCS) with sweetness level matched to the full sweetness sugar control for 6 months |
| Test beverage 1 for Habitual full-calorie CSD cohort, n=28 | Active comparator | Other: Flavored carbonated soft drink (CSD)Reduced sweetness (moderate sugar level) for 6 months |
| Test beverage 1 for Habitual low-calorie CSD cohort, n=28 | Active comparator | Other: Flavored carbonated soft drink (CSD)Reduced sweetness low calorie sweetener (LCS) with sweetness level matched to the moderate sugar sweetness level for 6 months |
| Test beverage 2 for Habitual full-calorie CSD cohort, n=28 | Active comparator | Other: Flavored carbonated soft drink (CSD)Step-wise sweetness reduction over 6 months. Month 1 is the full sweetness sugar control, followed by monthly sweetness reduction. Remains at the reduced sweetness level (moderate sugar level) from months 4-6. |
| Test beverage 2 for Habitual low-calorie CSD cohort, n=28 | Active comparator | Other: Flavored carbonated soft drink (CSD)Step-wise sweetness reduction over 6 months. Month 1 is the low calorie sweetener (LCS) sweetness equivalent of the full sweetness sugar control, followed by monthly LCS sweetness reduction (reductions equivalent to the corresponding sugar reduction arm sweetness levels). Remains at the reduced sweetness level (LCS equivalent of moderate sugar sweetness level) from months 4-6. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults 25-55 years of age
- Habitually consume regular or diet carbonated soft drinks (CSD)
- Willing and able to consume at least one CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
- Willing and able to complete questionnaires regarding dietary intake and sensory perception
- Has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete daily online questionnaires.
Key exclusion criteria (10 listed)
- Regular smoker (more than 1 cigarette per week)
- History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
- Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
- Extreme changes to physical activity
- Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
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 |
|---|---|---|
| Flavored carbonated soft drink (CSD)1-2 cans/day (330 ml per can) | Other | Control beverage for Habitual full-calorie CSD cohort, n=28, Control beverage for Habitual low-calorie CSD cohort, n=28, Test beverage 1 for Habitual full-calorie CSD cohort, n=28, Test beverage 1 for Habitual low-calorie CSD cohort, n=28, Test beverage 2 for Habitual full-calorie CSD cohort, n=28, Test beverage 2 for Habitual low-calorie CSD cohort, n=28 |
Primary outcome
Sweetness liking
Time frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Likert scale, 9 point scale from 1=Dislike extremely to 9=Like extremely
Sweetness intensity perception
Time frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness
1 secondary outcome
Dietary compensation for sweetness
Time frame: Assessed pre-intervention, then monthly x 6 months
Results and safety
The study was stopped early (reason given: Sponsor decision to stop study due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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.
Kathleen Kelley, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavored carbonated soft drink (CSD) in people with Sweetness Liking Adaptation, run by PepsiCo Global R&D 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Jun 2020. 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. 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 was stopped early (reason given: Sponsor decision to stop study due to COVID-19 pandemic). Results are not available in the source record.
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?
Sweetness liking (time frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6). 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?
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 16 Jun 2020.