ObesityNCT00768417
Availability of Lipids in Almonds in Healthy Individuals
An observational study of Obesity and Overweight, run by Purdue University at 1 site in United States.
Trial summary
Evidence indicates that almond consumption is associated with multiple health benefits. However, nuts are commonly excluded from diets on the basis that their high energy content may induce weight gain. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- 10 chews, 25 Chews and 40 Chews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2007
- Phase
- Observational
- 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
Study population: University and community sample
Who may be able to join
- 18-50 years of age
- BMI 20-25 kg/m2
- Full set of healthy teeth
- Weight stable (<3 kg change in past 3 mo)
Who cannot join
- Smoker
- Eating Disorders or high level of restraint
- Endocrine disorders
- Pregnant or lactating
- Allergic to nuts
- Taking medication likely to confound study outcomes (meds affecting appetite)
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University, Laboratory forSensory and Ingestive Studies
West Lafayette, Indiana, 47907
About this study
Official title: Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response
Evidence indicates that almond consumption is associated with multiple health benefits. However, nuts are commonly excluded from diets on the basis that their high energy content may induce weight gain. Evidence from numerous studies show that this is not the case, yet the mechanism responsible for the less than predicted effect on weight is unknown. This study aimed to examine the effects of increased mastication on lipid bioavailability and satiety related peptide released in humans. Its purpose is to provide valuable mechanistic data to support the results from previous completed clinical studies.
Read the detailed description
This cross-over study consisted of three study periods of four consecutive days separated by at least one week. During each day of the three study periods, participants were required to consume 55g of almonds split up into 5 g portions. They were required to chew the almonds 10, 25, or 40 times before swallowing, depending on the treatment. During each treatment period, all participants followed the same procedures over the four days. On day one after an overnight fast, participants reported to the laboratory and were presented with 11, 5 gram portions of almonds to chew 10, 25, or 40 times, depending on treatment arm. The participant remained in the laboratory for 4 hours post-almond consumption for measurements of blood and appetite. For the remainder of the 4 days, participants consumed all meals in the laboratory and collected all stools passed. On a separate occasion, recovered particle sizes of masticated almonds were measured by a mechanical sieving process. Individuals chewed almond samples either 10, 25 or 40 times and expectorated them into sieves.
- Conditions
- Obesity, Overweight
- Being tested
- 10 chews, 25 Chews, 40 Chews
- Keywords
- Nuts, Lipids, Mastication, Bioaccessibility, Satiety, Hormones, Human
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 chewsBehavioural
Also called Almonds
Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 10 times before swallowing.
25 ChewsBehavioural
Also called Almonds
Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 25 times before swallowing.
40 ChewsBehavioural
Also called Almonds
Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 40 times before swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants completed all 3-arms of this cross-over design study. Receives: Behavioral: 10 chews; Behavioral: 25 Chews; Behavioral: 40 Chews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
Measured: 3, 4 day periods
Secondary outcomes (1)
Particle size distribution as measured by mechanical sieving process
Measured: 3 separate sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startApr 2006
- Primary completionAug 2007
- Study completionAug 2007
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 ObesityStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, MPH, PhD, RD, Principal investigator, Purdue UniversityBridget A Cassady, B.S., Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768417
- Sponsor's protocol ID
- 0511003189
- Status last verified
- Nov 2013
- First submitted
- 7 Oct 2008
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cassady BA, Hollis JH, Fulford AD, Considine RV, Mattes RD. Mastication of almonds: effects of lipid bioaccessibility, appetite, and hormone response. Am J Clin Nutr. 2009 Mar;89(3):794-800. doi: 10.3945/ajcn.2008.26669. Epub 2009 Jan 14.
PubMed 19144727
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response
- ClinicalTrials.gov ID
- NCT00768417
- Acronym / sponsor ID
- 0511003189
- Conditions
- Obesity, Overweight
- Keywords
- Nuts, Lipids, Mastication, Bioaccessibility, Satiety, Hormones, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Apr 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Oct 2008 (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.
Evidence indicates that almond consumption is associated with multiple health benefits. However, nuts are commonly excluded from diets on the basis that their high energy content may induce weight gain. Evidence from numerous studies show that this is not the case, yet the mechanism responsible for the less than predicted effect on weight is unknown. This study aimed to examine the effects of increased mastication on lipid bioavailability and satiety related peptide released in humans. Its purpose is to provide valuable mechanistic data to support the results from previous completed clinical studies.
Detailed description
This cross-over study consisted of three study periods of four consecutive days separated by at least one week. During each day of the three study periods, participants were required to consume 55g of almonds split up into 5 g portions. They were required to chew the almonds 10, 25, or 40 times before swallowing, depending on the treatment. During each treatment period, all participants followed the same procedures over the four days. On day one after an overnight fast, participants reported to the laboratory and were presented with 11, 5 gram portions of almonds to chew 10, 25, or 40 times, depending on treatment arm. The participant remained in the laboratory for 4 hours post-almond consumption for measurements of blood and appetite. For the remainder of the 4 days, participants consumed all meals in the laboratory and collected all stools passed. On a separate occasion, recovered particle sizes of masticated almonds were measured by a mechanical sieving process. Individuals chewed almond samples either 10, 25 or 40 times and expectorated them into sieves.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: 10 chews, Behavioral: 25 Chews, Behavioral: 40 ChewsParticipants completed all 3-arms of this cross-over design study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University and community sample
Key inclusion criteria (4 listed)
- 18-50 years of age
- BMI 20-25 kg/m2
- Full set of healthy teeth
- Weight stable (<3 kg change in past 3 mo)
Key exclusion criteria (6 listed)
- Smoker
- Eating Disorders or high level of restraint
- Endocrine disorders
- Pregnant or lactating
- Allergic to nuts
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 |
|---|---|---|
| 10 chewsAlso: AlmondsParticipants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 10 times before swallowing. | Behavioural | Participants |
| 25 ChewsAlso: AlmondsParticipants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 25 times before swallowing. | Behavioural | Participants |
| 40 ChewsAlso: AlmondsParticipants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 40 times before swallowing. | Behavioural | Participants |
Primary outcome
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
Time frame: 3, 4 day periods
1 secondary outcome
Particle size distribution as measured by mechanical sieving process
Time frame: 3 separate sessions
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 Nov 2013.
- Derived from this study: PubMed 19144727Cassady BA, Hollis JH, Fulford AD, Considine RV, Mattes RD. Mastication of almonds: effects of lipid bioaccessibility, appetite, and hormone response. Am J Clin Nutr. 2009 Mar;89(3):794-800. doi: 10.3945/ajcn.2008.26669. Epub 2009 Jan 14.
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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.
Richard D Mattes, MPH, PhD, RD principal investigator
Purdue University
Bridget A Cassady, B.S. study director
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Purdue University 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 6 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 18 Nov 2013. 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?
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?
Lipid available for absorption as measured by stool collections, appetite measures, blood analysis (time frame: 3, 4 day periods). 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 NCT00768417, 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 18 Nov 2013.