HealthyNCT02034383
The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
A study testing Whole Almonds, Roasted Whole Almonds and Diced Almonds in people with Healthy and Focus: Effect of Processing on Energy Value of Almonds, run by David Baer at 1 site in United States.
Trial summary
The objective of this study is to measure the effect of processing (roasting, slicing, or grinding) on the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Focus: Effect of Processing on Energy Value of Almonds
- What is being tested?
- Whole Almonds, Roasted Whole Almonds and Diced Almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2014
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25 to 75 years at beginning of study
- BMI between 20 and 38 kg/m2
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 (controlled with certain medications)
- Fasting total blood cholesterol < 280 mg/dl
- Fasting triglycerides < 300 mg/dl
Who cannot join
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of bariatric or certain other surgeries related to weight control
Show all 13Show fewer
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 12 months
- Known (self-reported) allergy or adverse reaction to almonds or other nuts
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: Macronutrient Absorption From Almonds: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
The objective of this study is to measure the effect of processing (roasting, slicing, or grinding) on the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds.
Read the detailed description
The metabolizable energy values, or Atwater general factors, for protein, fat, and carbohydrate are commonly used to calculate the metabolizable energy of a diet. Atwater factors are based on average values of mixed diets and are not exact; thus, using these values could introduce an error in the calculated metabolizable energy of a particular food due to differences in chemical structure and availability. Studies have demonstrated that Atwater general factors overestimate the energy derived from protein and fat, as well as the measured metabolizable energy of mixed diets, particularly those that are high in dietary fiber. Studies are lacking, however, that examine how different processing methods affect the metabolizable energy of a food due to differences in chemical structure and availability.
- Being tested
- Control, Whole Almonds, Roasted Whole Almonds, Diced Almonds, Almond Butter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Controlled diet for 3 weeks with 0 servings/day of almonds.
Whole AlmondsOther
Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.
Roasted Whole AlmondsOther
Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.
Diced AlmondsOther
Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.
Almond ButterOther
Controlled diet for 3 weeks with 1.5 servings/day of almond butter.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Diet will consist of a controlled diet without almonds for 3 weeks. Receives: Other: Control |
| Whole Almonds | Experimental | Diet will consist of a controlled diet with whole almonds for 3 weeks. Receives: Other: Whole Almonds |
| Roasted Whole Almonds | Experimental | Diet will consist of a controlled diet with roasted whole almonds for 3 weeks. Receives: Other: Roasted Whole Almonds |
| Diced Almonds | Experimental | Diet will consist of a controlled diet with diced almonds for 3 weeks. Receives: Other: Diced Almonds |
| Almond Butter | Experimental | Diet will consist of a controlled diet with almond butter for 3 weeks. Receives: Other: Almond Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolizable Energy
The metabolizable energy value of almonds and almond butter will be calculated based on the chemical composition and energy content of the consumed diet and excreta.
Measured: End of each 3-week diet period
Secondary outcomes (3)
Digestibility
Fat, protein, and fiber digestibility will be calculated and the effect of almond on nutrient digestibility will be assessed.
Measured: End of each 3-week diet period
Almond nutrient metabolism
Blood and urine will be analyzed for appearance of almond nutrients and their metabolites.
Measured: End of each 3-week diet period
Biomarkers of cardiovascular disease
Blood will be analyzed for biomarkers of risk for cardiovascular disease and cancer such as oxidative stress and inflammatory markers.
Measured: End of each 3-week diet period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
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 HealthyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Baer
- Sponsor type
- US federal agency
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor-investigator, David Baer, USDA Beltsville Human Nutrition Research Center
- Investigators
- David J. Baer, Ph.D., Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034383
- Sponsor's protocol ID
- HS45
- Status last verified
- Feb 2015
- First submitted
- 9 Jan 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Novotny JA, Gebauer SK, Baer DJ. Discrepancy between the Atwater factor predicted and empirically measured energy values of almonds in human diets. Am J Clin Nutr. 2012 Aug;96(2):296-301. doi: 10.3945/ajcn.112.035782. Epub 2012 Jul 3.
PubMed 22760558
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macronutrient Absorption From Almonds: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
- ClinicalTrials.gov ID
- NCT02034383
- Acronym / sponsor ID
- HS45
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- David BaerUS federal agency
- Collaborators
- Almond Board of California
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Jan 2014 (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 objective of this study is to measure the effect of processing (roasting, slicing, or grinding) on the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds.
Detailed description
The metabolizable energy values, or Atwater general factors, for protein, fat, and carbohydrate are commonly used to calculate the metabolizable energy of a diet. Atwater factors are based on average values of mixed diets and are not exact; thus, using these values could introduce an error in the calculated metabolizable energy of a particular food due to differences in chemical structure and availability. Studies have demonstrated that Atwater general factors overestimate the energy derived from protein and fat, as well as the measured metabolizable energy of mixed diets, particularly those that are high in dietary fiber. Studies are lacking, however, that examine how different processing methods affect the metabolizable energy of a food due to differences in chemical structure and availability.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlDiet will consist of a controlled diet without almonds for 3 weeks. |
| Whole Almonds | Experimental | Other: Whole AlmondsDiet will consist of a controlled diet with whole almonds for 3 weeks. |
| Roasted Whole Almonds | Experimental | Other: Roasted Whole AlmondsDiet will consist of a controlled diet with roasted whole almonds for 3 weeks. |
| Diced Almonds | Experimental | Other: Diced AlmondsDiet will consist of a controlled diet with diced almonds for 3 weeks. |
| Almond Butter | Experimental | Other: Almond ButterDiet will consist of a controlled diet with almond butter for 3 weeks. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 25 to 75 years at beginning of study
- BMI between 20 and 38 kg/m2
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 (controlled with certain medications)
- Fasting total blood cholesterol < 280 mg/dl
Key exclusion criteria (13 listed)
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
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 |
|---|---|---|
| ControlControlled diet for 3 weeks with 0 servings/day of almonds. | Other | Control |
| Whole AlmondsControlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds. | Other | Whole Almonds |
| Roasted Whole AlmondsControlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds. | Other | Roasted Whole Almonds |
| Diced AlmondsControlled diet for 3 weeks with 1.5 servings/day of diced almonds. | Other | Diced Almonds |
| Almond ButterControlled diet for 3 weeks with 1.5 servings/day of almond butter. | Other | Almond Butter |
Primary outcome
Metabolizable Energy
Time frame: End of each 3-week diet period
The metabolizable energy value of almonds and almond butter will be calculated based on the chemical composition and energy content of the consumed diet and excreta.
3 secondary outcomes
Digestibility
Time frame: End of each 3-week diet period
Almond nutrient metabolism
Time frame: End of each 3-week diet period
Biomarkers of cardiovascular disease
Time frame: End of each 3-week diet period
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 13 Feb 2015.
- Background: PubMed 22760558Novotny JA, Gebauer SK, Baer DJ. Discrepancy between the Atwater factor predicted and empirically measured energy values of almonds in human diets. Am J Clin Nutr. 2012 Aug;96(2):296-301. doi: 10.3945/ajcn.112.035782. Epub 2012 Jul 3.
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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.
David J. Baer, Ph.D. principal investigator
USDA Beltsville Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Almonds, Roasted Whole Almonds and Diced Almonds in people with Healthy and Focus: Effect of Processing on Energy Value of Almonds, run by David Baer 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 6 inclusion and 13 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 13 Feb 2015. 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?
Metabolizable Energy (time frame: End of each 3-week diet period). 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 NCT02034383, 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 13 Feb 2015.