Metabolizable Energy of WalnutsNCT01832909
The Measured Energy Value of Walnuts in the Human Diet
A study testing Walnut Diet in people with Metabolizable Energy of Walnuts, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The objective of this study is to measure the energy value of walnuts in the human diet and study molecular mechanisms that may help explain the beneficial health effects of walnuts. The hypothesis is that there will be less metabolizable energy in walnuts due to decreased fat digestibility. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolizable Energy of Walnuts
- What is being tested?
- Walnut Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25 to 65 years at beginning of study
- Body mass index 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 14Show fewer
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 weeks prior to any intervention period
- 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 walnuts 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 Walnuts: The Measured Energy Value of Walnuts in the Human Diet
The objective of this study is to measure the energy value of walnuts in the human diet and study molecular mechanisms that may help explain the beneficial health effects of walnuts. The hypothesis is that there will be less metabolizable energy in walnuts due to decreased fat digestibility.
Read the detailed description
Previous studies have demonstrated that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. The aim of this study is to determine the energy value of walnuts in the human diet and to probe mechanisms by which walnuts impart health benefits. The metabolizable energy value of walnuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of walnuts than simply calculating energy value based on Atwater factors. In addition to determining the energy value of walnuts, we will evaluate the effects of walnut-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by walnut consumption.
- Conditions
- Metabolizable Energy of Walnuts
- Being tested
- Walnut Diet, Control Diet
- Keywords
- metabolizable energy, walnuts, Atwater factors, energy value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut DietOther
Controlled diet with 1.5 oz/d of walnuts.
Control DietOther
Controlled diet without walnuts.
| Study group | Role | What they receive |
|---|---|---|
| Walnut Diet first, then Control Diet | Experimental | Controlled diet with 1.5 oz/d of walnuts, followed by controlled diet without walnuts. Receives: Other: Walnut Diet; Other: Control Diet |
| Control Diet first, then Walnut Diet | Experimental | Controlled diet without almonds first (control), then controlled diet with 1.5 oz/d of almonds. Receives: Other: Walnut Diet; Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolizable Energy
Metabolizable energy content will be calculated according to the methods of Novotny et al. (2012). Fat, protein, and fiber digestibility will be calculated and the effect of walnuts on nutrient digestibility will be assessed.
Measured: Each three weeks, up to 6 weeks
Secondary outcomes (3)
Gene expression
Gene expression in whole blood will be evaluated through global gene expression using the Affymetrix platform. Changes in specific genes observed with global gene expression technology will be confirmed through reverse transcription polymerase chain reaction.
Measured: At the end of each 3-week intervention period
Biomarkers of oxidative stress/inflammation
Analysis of markers such as oxidized-low density lipoprotein and inflammatory markers (C-reactive protein, interleukin-1, interleukin-6, tumor necrosis factor-alpha).
Measured: End of each 3-week intervention period
Measure of walnut nutrients and metabolites
Blood and urine will be analyzed for appearance of walnut nutrients and their metabolites.
Measured: End of each 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolizable Energy of WalnutsStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- California Walnut Board
- Responsible party
- Principal investigator, David Baer, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832909
- Sponsor's protocol ID
- HS43
- Status last verified
- Sep 2013
- First submitted
- 8 Apr 2013
- Last updated
- 17 Sep 2013
- 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 22760558Holscher HD, Guetterman HM, Swanson KS, An R, Matthan NR, Lichtenstein AH, Novotny JA, Baer DJ. Walnut Consumption Alters the Gastrointestinal Microbiota, Microbially Derived Secondary Bile Acids, and Health Markers in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):861-867. doi: 10.1093/jn/nxy004.
PubMed 29726951Baer DJ, Gebauer SK, Novotny JA. Walnuts Consumed by Healthy Adults Provide Less Available Energy than Predicted by the Atwater Factors. J Nutr. 2016 Jan;146(1):9-13. doi: 10.3945/jn.115.217372. Epub 2015 Nov 18.
PubMed 26581681
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macronutrient Absorption From Walnuts: The Measured Energy Value of Walnuts in the Human Diet
- ClinicalTrials.gov ID
- NCT01832909
- Acronym / sponsor ID
- HS43
- Conditions
- Metabolizable Energy of Walnuts
- Keywords
- metabolizable energy, walnuts, Atwater factors, energy value
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Collaborators
- California Walnut Board
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2013 (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 energy value of walnuts in the human diet and study molecular mechanisms that may help explain the beneficial health effects of walnuts. The hypothesis is that there will be less metabolizable energy in walnuts due to decreased fat digestibility.
Detailed description
Previous studies have demonstrated that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. The aim of this study is to determine the energy value of walnuts in the human diet and to probe mechanisms by which walnuts impart health benefits. The metabolizable energy value of walnuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of walnuts than simply calculating energy value based on Atwater factors. In addition to determining the energy value of walnuts, we will evaluate the effects of walnut-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by walnut consumption.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut Diet first, then Control Diet | Experimental | Other: Walnut Diet, Other: Control DietControlled diet with 1.5 oz/d of walnuts, followed by controlled diet without walnuts. |
| Control Diet first, then Walnut Diet | Experimental | Other: Walnut Diet, Other: Control DietControlled diet without almonds first (control), then controlled diet with 1.5 oz/d of almonds. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 25 to 65 years at beginning of study
- Body mass index 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 (14 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 |
|---|---|---|
| Walnut DietControlled diet with 1.5 oz/d of walnuts. | Other | Control Diet first, then Walnut Diet, Walnut Diet first, then Control Diet |
| Control DietControlled diet without walnuts. | Other | Control Diet first, then Walnut Diet, Walnut Diet first, then Control Diet |
Primary outcome
Metabolizable Energy
Time frame: Each three weeks, up to 6 weeks
Metabolizable energy content will be calculated according to the methods of Novotny et al. (2012). Fat, protein, and fiber digestibility will be calculated and the effect of walnuts on nutrient digestibility will be assessed.
3 secondary outcomes
Gene expression
Time frame: At the end of each 3-week intervention period
Biomarkers of oxidative stress/inflammation
Time frame: End of each 3-week intervention period
Measure of walnut nutrients and metabolites
Time frame: End of each 3-week intervention 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 17 Sep 2013.
- 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.
- Derived from this study: PubMed 29726951Holscher HD, Guetterman HM, Swanson KS, An R, Matthan NR, Lichtenstein AH, Novotny JA, Baer DJ. Walnut Consumption Alters the Gastrointestinal Microbiota, Microbially Derived Secondary Bile Acids, and Health Markers in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):861-867. doi: 10.1093/jn/nxy004.
- Derived from this study: PubMed 26581681Baer DJ, Gebauer SK, Novotny JA. Walnuts Consumed by Healthy Adults Provide Less Available Energy than Predicted by the Atwater Factors. J Nutr. 2016 Jan;146(1):9-13. doi: 10.3945/jn.115.217372. Epub 2015 Nov 18.
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 Walnut Diet in people with Metabolizable Energy of Walnuts, run by USDA Beltsville Human Nutrition Research Center 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 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 17 Sep 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?
Metabolizable Energy (time frame: Each three weeks, up to 6 weeks). 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 NCT01832909, which also lists 3 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 17 Sep 2013.