Lack of SatietyNCT01379911
Developing Methods for Completing Future Satiety Studies
A study testing Yogurt in people with Lack of Satiety, run by University of Guelph at 1 site in Canada.
Trial summary
Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lack of Satiety
- What is being tested?
- Yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Oct 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
- BMI of 20.0-24.9 kg/m2
- Regular yogurt consumers (i.e. > 3 servings per week)
Who cannot join
- Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
- History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
- Vegans or vegetarians who exclude dairy products
- Milk allergies or any other food allergies
- Anyone with known anaphylactic allergic reactions, food or otherwise
- Dislike or unwillingness to consume study foods
Show all 14Show fewer
- Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.
- BMI <20.0 or > 25.0 kg/m2
- Current participation in diet/weight-loss programs and/or changes of > 5 kg body weight within the past 6 months
- Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)
- Unusual sleep patterns (i.e. shift workers)
- High habitual intake of caffeinated beverages or alcohol
- Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire
- Smokers
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, N1G2W1
About this study
Official title: Developing and Validating a Method for Satiety Studies
Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.
This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.
- Conditions
- Lack of Satiety
- Being tested
- Yogurt
- Keywords
- Satiety, Food intake, Yogurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogurtOther
| Study group | Role | What they receive |
|---|---|---|
| Yogurt with added inulin | Active comparator | Yogurt with 6g of added inulin Receives: Other: Yogurt |
| Regular yogurt | Placebo comparator | Regular yogurt without added inulin Receives: Other: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported ratings of satiety
The study consists of two trial days (pre- and post home consumption) per study period, one for each of 2 yogurts. Each study visit involves a 4-hour stay at the HNRU. The pre-study visit will be followed by a 6-day yogurt self-administration period where participants will consume the assigned yogurt at breakfast. Thus, the acute satiety effects of the yogurts will be replicated in a controlled (laboratory) setting and evaluated over a 6-day period in an uncontrolled (home/lifestyle) environment.
Measured: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
Secondary outcomes (1)
Food intake
Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startFeb 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Tucker, University of Guelph
- Investigators
- Amanda J Wright, Ph.D., Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379911
- Sponsor's protocol ID
- 11AP036
- Status last verified
- Jan 2016
- First submitted
- 15 Jun 2011
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating a Method for Satiety Studies
- ClinicalTrials.gov ID
- NCT01379911
- Acronym / sponsor ID
- 11AP036
- Conditions
- Lack of Satiety
- Keywords
- Satiety, Food intake, Yogurt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Jun 2011 (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.
Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.
This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogurt with added inulin | Active comparator | Other: YogurtYogurt with 6g of added inulin |
| Regular yogurt | Placebo comparator | Other: YogurtRegular yogurt without added inulin |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
- BMI of 20.0-24.9 kg/m2
- Regular yogurt consumers (i.e. > 3 servings per week)
Key exclusion criteria (14 listed)
- Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
- History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
- Vegans or vegetarians who exclude dairy products
- Milk allergies or any other food allergies
- Anyone with known anaphylactic allergic reactions, food or otherwise
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 |
|---|---|---|
| Yogurt | Other | Regular yogurt, Yogurt with added inulin |
Primary outcome
Self-reported ratings of satiety
Time frame: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
The study consists of two trial days (pre- and post home consumption) per study period, one for each of 2 yogurts. Each study visit involves a 4-hour stay at the HNRU. The pre-study visit will be followed by a 6-day yogurt self-administration period where participants will consume the assigned yogurt at breakfast. Thus, the acute satiety effects of the yogurts will be replicated in a controlled (laboratory) setting and evaluated over a 6-day period in an uncontrolled (home/lifestyle) environment.
1 secondary outcome
Food intake
Time frame: One week
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 21 Jan 2016.
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.
Amanda J Wright, Ph.D. principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt in people with Lack of Satiety, run by University of Guelph at 1 site in Canada.
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 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 21 Jan 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 Canada. 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?
Self-reported ratings of satiety (time frame: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.). 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 21 Jan 2016.