HealthyPhase 1/2NCT00285571
Dietary Variety Versus Dietary Fat Effects in Energy Intake
A Phase 1/2 study of Healthy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2007
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Healthy adults age 18-5 y with BMI 20-35 kg/m
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Variety vs Dietary Fat Effects on Energy Intake
The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.
We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood.
Read the detailed description
The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.
We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood
- Conditions
- Healthy
- Being tested
- Controlled Feeding Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Feeding InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy intake at two weeks.
Secondary outcomes (1)
Two week changes in body weight, fat, taste preferences, nutrient composition of self-selected dietary intake, eating patterns of self-selected dietary intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startSep 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Megan McCrory, PhD, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285571
- Sponsor's protocol ID
- DK62400 (completed 2007)
- Status last verified
- Mar 2010
- First submitted
- 31 Jan 2006
- Last updated
- 18 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Variety vs Dietary Fat Effects on Energy Intake
- ClinicalTrials.gov ID
- NCT00285571
- Acronym / sponsor ID
- DK62400 (completed 2007)
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Feb 2006 (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 relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.
We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood.
Detailed description
The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar.
We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Controlled Feeding Intervention | Behavioural | – |
Primary outcome
Change in energy intake at two weeks.
1 secondary outcome
Two week changes in body weight, fat, taste preferences, nutrient composition of self-selected dietary intake, eating patterns of self-selected dietary intake.
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 18 Mar 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Megan McCrory, PhD principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Healthy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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?
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 18 Mar 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 energy intake at two weeks.. 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 18 Mar 2010.