Focus of the Study is SatietyNCT01713114
Effects of a Variety of Meals on Satiety
A study testing Acute measures of satiety and food intake at next meal in people with Focus of the Study is Satiety, run by The Hillshire Brands Company at 1 site in United States.
Trial summary
The primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Satiety
- What is being tested?
- Acute measures of satiety and food intake at next meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2013
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal Females
- Ages 18-55
- BMI between 18.5-29.9
- Willing to maintain weight throughout study period
Who cannot join
- Subject has a history of any surgical intervention for the treatment of obesity
- Recent history or use of weight loss drugs, herbal supplements or on a dieting program or trying to loose weight
- Gains or loses more than 6 pounds over the study period
- Current or history of an eating disorder
- Restrained eater
- Excludes any foods or meals from their diet
Show all 11Show fewer
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, gastrointestinal, biliary, pancreatic or neurologic disorders
- Signs of an infection
- Heavy user of caffeine or alcohol
- Unconventional sleep patterns (e.g. works 3rd shift)
- Subject is pregnant or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biofortis Clinical Research
Addison, Illinois, 60101
Andrea Lawless, MD, Andrea.Lawless@mxns.com
Kristen Sanoshy, kristen.sanoshy@mxns.com
About this study
Official title: A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety
The primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions.
Read the detailed description
Satiety refers to feelings of fullness or lack of desire to eat following consumption of a food or meal. A number of dietary factors have been shown to influence satiety, including food volume, food weight, energy density, food palatability, and certain food ingredients. The nutritional composition of a meal appears to also play a significant role in an individual's feelings of satiety and ability to stay full until the next meal.
- Conditions
- Focus of the Study is Satiety
- Being tested
- Acute measures of satiety and food intake at next meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute measures of satiety and food intake at next mealOther
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate | Experimental | Not described Receives: Other: Acute measures of satiety and food intake at next meal |
| Moderate carbohydrate | Experimental | Not described Receives: Other: Acute measures of satiety and food intake at next meal |
| Higher Carbohydrate | Experimental | Not described Receives: Other: Acute measures of satiety and food intake at next meal |
| Meal Skipping | Placebo comparator | Not described Receives: Other: Acute measures of satiety and food intake at next meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Area under the Curve - Visual Analog Scale
Measured: Acute - up to 4 hrs
Secondary outcomes (1)
Individual satiety measures - Area under the curve
Measured: 4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013 (estimated)
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 Focus of the Study is SatietyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hillshire Brands Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713114
- Sponsor's protocol ID
- PRV1223
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
Publications
Rains TM, Leidy HJ, Sanoshy KD, Lawless AL, Maki KC. A randomized, controlled, crossover trial to assess the acute appetitive and metabolic effects of sausage and egg-based convenience breakfast meals in overweight premenopausal women. Nutr J. 2015 Feb 10;14:17. doi: 10.1186/s12937-015-0002-7.
PubMed 25889354
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety
- ClinicalTrials.gov ID
- NCT01713114
- Acronym / sponsor ID
- PRV1223
- Conditions
- Focus of the Study is Satiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The Hillshire Brands CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 24 Oct 2012 (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 primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions.
Detailed description
Satiety refers to feelings of fullness or lack of desire to eat following consumption of a food or meal. A number of dietary factors have been shown to influence satiety, including food volume, food weight, energy density, food palatability, and certain food ingredients. The nutritional composition of a meal appears to also play a significant role in an individual's feelings of satiety and ability to stay full until the next meal.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate | Experimental | Other: Acute measures of satiety and food intake at next meal |
| Moderate carbohydrate | Experimental | Other: Acute measures of satiety and food intake at next meal |
| Higher Carbohydrate | Experimental | Other: Acute measures of satiety and food intake at next meal |
| Meal Skipping | Placebo comparator | Other: Acute measures of satiety and food intake at next meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- premenopausal Females
- Ages 18-55
- BMI between 18.5-29.9
- Willing to maintain weight throughout study period
Key exclusion criteria (11 listed)
- Subject has a history of any surgical intervention for the treatment of obesity
- Recent history or use of weight loss drugs, herbal supplements or on a dieting program or trying to loose weight
- Gains or loses more than 6 pounds over the study period
- Current or history of an eating disorder
- Restrained eater
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 |
|---|---|---|
| Acute measures of satiety and food intake at next meal | Other | Higher Carbohydrate, Low carbohydrate, Meal Skipping, Moderate carbohydrate |
Primary outcome
Composite Area under the Curve - Visual Analog Scale
Time frame: Acute - up to 4 hrs
1 secondary outcome
Individual satiety measures - Area under the curve
Time frame: 4 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Derived from this study: PubMed 25889354Rains TM, Leidy HJ, Sanoshy KD, Lawless AL, Maki KC. A randomized, controlled, crossover trial to assess the acute appetitive and metabolic effects of sausage and egg-based convenience breakfast meals in overweight premenopausal women. Nutr J. 2015 Feb 10;14:17. doi: 10.1186/s12937-015-0002-7.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute measures of satiety and food intake at next meal in people with Focus of the Study is Satiety, run by The Hillshire Brands Company 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Area under the Curve - Visual Analog Scale (time frame: Acute - up to 4 hrs). 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 NCT01713114, 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 24 Oct 2012.