OverweightNCT02360787
The Effects of Including Almonds in a Weight Loss Trial
A study testing Energy restriction and Almonds (15% kcal/day) in people with Overweight and Obesity, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Energy restriction and Almonds (15% kcal/day)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult participants
- Overweight or obese (BMI 25-40 kg/m2)
- Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
- No nut allergies
- Willing to comply to study protocol and to eat test meals
Who cannot join
- Those not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.
Read the detailed description
The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.
- Conditions
- Overweight, Obesity
- Being tested
- Energy restriction, Almonds (15% kcal/day)
- Keywords
- Almonds, Energy restriction, Obesity, Body weight, Body fat, Blood pressure, Cognitive function
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy restrictionBehavioural
Almonds (15% kcal/day)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Energy restriction | Experimental | Energy restriction (-500 kcal/day) (N=40), where participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits to support weight loss. Participants will also be asked to avoid all nuts during the intervention period. Receives: Behavioral: Energy restriction |
| Energy restriction with almonds | Experimental | Energy restriction (-500 kcal/day) with dry-roasted, lightly salted almonds supplying 15% of estimated energy requirement. Participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits. Energy from almonds will be accounted for during dietary modeling so that a 500 kcal/day deficit is achieved. Receives: Behavioral: Energy restriction; Behavioral: Almonds (15% kcal/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks
Measured: 12 weeks
Blood pressure
Blood pressure measurements assessed at baseline, week-4, week-8 and week-12
Measured: 12 weeks
Post-lunch cognitive function
Cognitive function assessments will be performed after a standard lunch at baseline and week 12
Measured: 12 weeks
Secondary outcomes (4)
Fasting blood biochemistries
Fasting glucose, insulin, lipids and vitamin E over 12 weeks
Measured: 12 weeks
Dietary intake
Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10
Measured: 10 weeks
Appetite ratings
Appetite ratings assessed at baseline, week-4, week-8 and week-12
Measured: 12 weeks
Physical activity
Physical activity assessed at baseline, week-4, week-8 and week-12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360787
- Sponsor's protocol ID
- 055-030
- Status last verified
- Jan 2018
- First submitted
- 20 Nov 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dhillon J, Ferreira CR, Sobreira TJP, Mattes RD. Multiple Reaction Monitoring Profiling to Assess Compliance with an Almond Consumption Intervention. Curr Dev Nutr. 2017 Sep 6;1(9):e001545. doi: 10.3945/cdn.117.001545. eCollection 2017 Sep.
PubMed 29955720Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.
PubMed 27807041
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
- ClinicalTrials.gov ID
- NCT02360787
- Acronym / sponsor ID
- 055-030
- Conditions
- Overweight, Obesity
- Keywords
- Almonds, Energy restriction, Obesity, Body weight, Body fat, Blood pressure, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Oct 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Feb 2015 (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 purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.
Detailed description
The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy restriction | Experimental | Behavioral: Energy restrictionEnergy restriction (-500 kcal/day) (N=40), where participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits to support weight loss. Participants will also be asked to avoid all nuts during the intervention period. |
| Energy restriction with almonds | Experimental | Behavioral: Energy restriction, Behavioral: Almonds (15% kcal/day)Energy restriction (-500 kcal/day) with dry-roasted, lightly salted almonds supplying 15% of estimated energy requirement. Participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits. Energy from almonds will be accounted for during dietary modeling so that a 500 kcal/day deficit is achieved. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult participants
- Overweight or obese (BMI 25-40 kg/m2)
- Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
- No nut allergies
- Willing to comply to study protocol and to eat test meals
Key exclusion criteria (1 listed)
- Those not meeting inclusion criteria.
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 |
|---|---|---|
| Energy restriction | Behavioural | Energy restriction, Energy restriction with almonds |
| Almonds (15% kcal/day) | Behavioural | Energy restriction with almonds |
Primary outcome
Anthropometric measurements
Time frame: 12 weeks
Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks
Blood pressure
Time frame: 12 weeks
Blood pressure measurements assessed at baseline, week-4, week-8 and week-12
Post-lunch cognitive function
Time frame: 12 weeks
Cognitive function assessments will be performed after a standard lunch at baseline and week 12
4 secondary outcomes
Fasting blood biochemistries
Time frame: 12 weeks
Dietary intake
Time frame: 10 weeks
Appetite ratings
Time frame: 12 weeks
Physical activity
Time frame: 12 weeks
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 Jan 2018.
- Derived from this study: PubMed 29955720Dhillon J, Ferreira CR, Sobreira TJP, Mattes RD. Multiple Reaction Monitoring Profiling to Assess Compliance with an Almond Consumption Intervention. Curr Dev Nutr. 2017 Sep 6;1(9):e001545. doi: 10.3945/cdn.117.001545. eCollection 2017 Sep.
- Derived from this study: PubMed 27807041Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.
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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 Energy restriction and Almonds (15% kcal/day) in people with Overweight and Obesity, 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 5 inclusion and 1 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 Jan 2018. 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?
Anthropometric measurements (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT02360787, which also lists 2 linked publications.
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 Jan 2018.