Nutritional Physiological PhenomenaDEB PilotNCT03190993
The DEB Pilot Study
A study testing Sugar Sweetened Solid Treatment and Sugar Sweetened Beverage Treatment in people with Nutritional Physiological Phenomena and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Physiological Phenomena, Obesity
- What is being tested?
- Sugar Sweetened Solid Treatment and Sugar Sweetened Beverage Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 21 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20 - 40
Who cannot join
- Diabetes (Type 1 or 2)
- Prediabetes
- Active cancer
- Serious digestive disorders
- Other conditions that affect metabolism or body weight
- Uncontrolled Thyroid disorder (controlled = 6 months of medication)
Show all 14Show fewer
- Unable to consume study foods
- Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)
- Pregnancy
- Intentions of becoming pregnant in the next 2 months
- Women who have undergone partial hysterectomy with intact ovary function
- Current or past alcohol or drug abuse problem
- Allergy or intolerance to study product ingredients.
- Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Diet Composition and Energy Balance Pilot Study
The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.
Read the detailed description
Dose: Participants are to consume 1 unit per day of the study product.
Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.
- Conditions
- Nutritional Physiological Phenomena, Obesity
- Being tested
- Sugar Sweetened Solid Treatment, Sugar Sweetened Beverage Treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar Sweetened Solid TreatmentOther
Consume Sugar Sweetened Solid Treatment (product) daily.
Sugar Sweetened Beverage TreatmentOther
Also called SSB Treatment
Consume Sugar Sweetened Beverage Treatment (product) daily.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Sweetened Solid Treatment | Active comparator | A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Receives: Other: Sugar Sweetened Solid Treatment |
| Sugar Sweetened Beverage Treatment | Active comparator | 20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. Receives: Other: Sugar Sweetened Beverage Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight
Change from baseline in body weight at 1 month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start21 Jul 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nutritional Physiological PhenomenaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Martin, Corby, K., M.D., Owen T. Carmichael
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190993
- Sponsor's protocol ID
- 6218
- Acronym
- DEB Pilot
- Status last verified
- Oct 2020
- First submitted
- 15 Jun 2017
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diet Composition and Energy Balance Pilot Study
- ClinicalTrials.gov ID
- NCT03190993
- Acronym / sponsor ID
- DEB Pilot / 6218
- Conditions
- Nutritional Physiological Phenomena, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Martin, Corby, K., M.D., Owen T. Carmichael
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Posted 13 May 2020
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 the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.
Detailed description
Dose: Participants are to consume 1 unit per day of the study product.
Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
| Arm | Type | Receives |
|---|---|---|
| Sugar Sweetened Solid Treatment | Active comparator | Other: Sugar Sweetened Solid TreatmentA solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. |
| Sugar Sweetened Beverage Treatment | Active comparator | Other: Sugar Sweetened Beverage Treatment20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 20 - 40
Key exclusion criteria (14 listed)
- Diabetes (Type 1 or 2)
- Prediabetes
- Active cancer
- Serious digestive disorders
- Other conditions that affect metabolism or body weight
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 |
|---|---|---|
| Sugar Sweetened Solid TreatmentConsume Sugar Sweetened Solid Treatment (product) daily. | Other | Sugar Sweetened Solid Treatment |
| Sugar Sweetened Beverage TreatmentAlso: SSB TreatmentConsume Sugar Sweetened Beverage Treatment (product) daily. | Other | Sugar Sweetened Beverage Treatment |
Primary outcome
Change From Baseline in Body Weight
Time frame: 1 month
Change from baseline in body weight at 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Sugar Sweetened Solid Treatment and Sugar Sweetened Beverage Treatment in people with Nutritional Physiological Phenomena and Obesity, run by Pennington Biomedical 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 1 inclusion and 14 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 19 Oct 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. 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?
Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Body Weight (time frame: 1 month). 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 19 Oct 2020.