HealthyAPISNCT03526120
Pistachio Intake, Satiety and Body Weight Control in Healthy Adult Women
A study testing Pistachio in people with Healthy, run by Rene' Yamashiro at 1 site in France.
Trial summary
The main goal of the study is to confirm that, due to their rich nutritional content in protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and magnesium), the regular consumption of the recommended amount of pistachios by adult women will elicit appropriate satiety and compensation in the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pistachio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2018to Aug 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women;
- Age: lower age limit 18 years, upper age limit: 50 years (included);
- Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
- Habitual energy intake, as indicated by an initial intake report (diary method, three days) within the 95% confidence interval (CI) of the habitual energy intake of a similar population (as provided by internal reference data collected by CREABio-RA from previous studies in similar conditions);
- Participant not pregnant, not presently breast feeding or having breastfed in the last 3 months, and not planning to become pregnant during the study (negative pregnancy test at inclusion or morning of V1);
- Pre-menopausal participant on effective contraception since at least 3 months (regular 28-day cycle) and who agree to continue their contraception throughout the study;
- Participant registered with the French Social Security;
- participant having signed informed consent
Who cannot join
- Subject under legal protection or deprived of liberty by judicial or administrative decision.
- Currently diagnosed somatic pathology;
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
- Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
- High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
- Strong initial dislike of nuts, specially pistachios, as revealed by questioning about food habits initial dietary questionnaire;
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- Habitual consumption of pistachios as revealed by the 3-d intake report (more than twice a week);
- Participants smoking more than 10 cigarettes per day or planning to stop smoking in the next 3 months;
- Currently pregnant, lactating (as specified in article L1121-5 of the Public Health Code) or less than 6 month post-partum;
- Any kind of food allergy, especially allergies or intolerance to nuts;
- Participant not capable of understanding the constraints of the study, who does not agree to abide, and/or unable to communicate normally with investigators;
- Person currently participating in another clinical study, or having used up her annual entitlement to compensation for participation in biomedical studies (4500 €).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CreaBio Rhône-Alpes
Givors, Rhône, F-69700
Marc Fantino, MD, PhD, Pr, +33 481 653 365, marc.fantino@creabio-ra.com
Marc Fantino, MD, PhD, Pr
About this study
Official title: Acute Satiety and Energy Compensation After Consumption of a Pistachio Snack and Longer Term Consequences on Satiety, Anthropometry, and Body Composition After a Nutritional Intervention With Daily Consumption of the Pistachio Snack
The main goal of the study is to confirm that, due to their rich nutritional content in protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and magnesium), the regular consumption of the recommended amount of pistachios by adult women will elicit appropriate satiety and compensation in the daily energy intake, and improve diet quality, anthropometry and body composition.
Read the detailed description
The expected endpoint is to demonstrate that the daily consumption of a snack of pistachios by healthy women, as recommended in the next National Program for Nutrition and Health (program PNNS, France), elicits adequate satiety and does not induce weight gain but rather improves diet quality, body composition and body fat mass distribution (less abdominal fat).
The study will be a 16 weeks randomized controlled open trial, single-center, including two parallel groups of 30 female participants (block randomization stratified on habitual energy intake and initial body weight according to the consort-statement checklist).
The main working hypothesis is a demonstration of the "non inferiority" of the effects of the pistachio intervention on body weight versus no snack consumption. The investigators hypothesize that there will be no significant difference in body weight change due to pistachios consumption. The two-sided 95% confidence interval on the intra-patient difference (before minus after the pistachio intervention) will be provided through the appropriate contrasts.
- Conditions
- Healthy
- Being tested
- Pistachio
- Keywords
- Human subjects, Pistachio snack, Body mass index, Energy intake, Fat mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PistachioOther
Dailly 44 g unsalted pistachios snack for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pistachio diet | Experimental | Incorporates 44 g (1 serving) of pistachios into a daily diet Receives: Other: Pistachio |
| Control | No intervention | No pistachio consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kg
Measured: 12 weeks
Secondary outcomes (4)
Total daily energy intake
Total daily energy intake in kcal
Measured: 12 weeks
Appetite ratings
Appetite ratings measured on visual analogic scalls of 100 mm
Measured: 12 weeks
Body weight index
Body weight index in kg/m2
Measured: 12 weeks
Body fat mass
Body fat mass in kg
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 posted16 May 2018
- Study start27 Feb 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups according a block randomization stratified on habitual energy intake and initial body weight (as in http://www.consort-statement.org/checklists/view/32--consort-2010/87-randomisation-type, § 8B). Randomisation: type).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rene' Yamashiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rene' Yamashiro, American Pistachio Growers
- Investigators
- Marc FANTINO, MD, PhD, Pr., Principal investigator, CreaBio Rhône-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526120
- Sponsor's protocol ID
- APIS
- Other IDs
- ID RCB : 20107-A031, APG01-0117
- Acronym
- APIS
- Status last verified
- May 2018
- First submitted
- 22 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fantino M, Bichard C, Mistretta F, Bellisle F. Daily consumption of pistachios over 12 weeks improves dietary profile without increasing body weight in healthy women: A randomized controlled intervention. Appetite. 2020 Jan 1;144:104483. doi: 10.1016/j.appet.2019.104483. Epub 2019 Oct 8.
PubMed 31604062
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Satiety and Energy Compensation After Consumption of a Pistachio Snack and Longer Term Consequences on Satiety, Anthropometry, and Body Composition After a Nutritional Intervention With Daily Consumption of the Pistachio Snack
- ClinicalTrials.gov ID
- NCT03526120
- Acronym / sponsor ID
- APIS / APIS
- Conditions
- Healthy
- Keywords
- Human subjects, Pistachio snack, Body mass index, Energy intake, Fat mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rene' YamashiroUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 16 May 2018 (actual)
- 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 main goal of the study is to confirm that, due to their rich nutritional content in protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and magnesium), the regular consumption of the recommended amount of pistachios by adult women will elicit appropriate satiety and compensation in the daily energy intake, and improve diet quality, anthropometry and body composition.
Detailed description
The expected endpoint is to demonstrate that the daily consumption of a snack of pistachios by healthy women, as recommended in the next National Program for Nutrition and Health (program PNNS, France), elicits adequate satiety and does not induce weight gain but rather improves diet quality, body composition and body fat mass distribution (less abdominal fat).
The study will be a 16 weeks randomized controlled open trial, single-center, including two parallel groups of 30 female participants (block randomization stratified on habitual energy intake and initial body weight according to the consort-statement checklist).
The main working hypothesis is a demonstration of the "non inferiority" of the effects of the pistachio intervention on body weight versus no snack consumption. The investigators hypothesize that there will be no significant difference in body weight change due to pistachios consumption. The two-sided 95% confidence interval on the intra-patient difference (before minus after the pistachio intervention) will be provided through the appropriate contrasts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups according a block randomization stratified on habitual energy intake and initial body weight (as in http://www.consort-statement.org/checklists/view/32--consort-2010/87-randomisation-type, § 8B). Randomisation: type).
| Arm | Type | Receives |
|---|---|---|
| Pistachio diet | Experimental | Other: PistachioIncorporates 44 g (1 serving) of pistachios into a daily diet |
| Control | No intervention | –No pistachio consumption |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women;
- Age: lower age limit 18 years, upper age limit: 50 years (included);
- Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
- Habitual energy intake, as indicated by an initial intake report (diary method, three days) within the 95% confidence interval (CI) of the habitual energy intake of a similar population (as provided by internal reference data collected by CREABio-RA from previous studies in similar conditions);
- Participant not pregnant, not presently breast feeding or having breastfed in the last 3 months, and not planning to become pregnant during the study (negative pregnancy test at inclusion or morning of V1);
Key exclusion criteria (12 listed)
- Subject under legal protection or deprived of liberty by judicial or administrative decision.
- Currently diagnosed somatic pathology;
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
- Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
- High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
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 |
|---|---|---|
| PistachioDailly 44 g unsalted pistachios snack for 12 weeks | Other | Pistachio diet |
Primary outcome
Body weight
Time frame: 12 weeks
Body weight in kg
4 secondary outcomes
Total daily energy intake
Time frame: 12 weeks
Appetite ratings
Time frame: 12 weeks
Body weight index
Time frame: 12 weeks
Body fat mass
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 31604062Fantino M, Bichard C, Mistretta F, Bellisle F. Daily consumption of pistachios over 12 weeks improves dietary profile without increasing body weight in healthy women: A randomized controlled intervention. Appetite. 2020 Jan 1;144:104483. doi: 10.1016/j.appet.2019.104483. Epub 2019 Oct 8.
- Individual participant dataSharing planned: No
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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.
Marc FANTINO, MD, PhD, Pr. principal investigator
CreaBio Rhône-Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachio in people with Healthy, run by Rene' Yamashiro at 1 site in France.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 May 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc FANTINO, MD, PhD, Pr. (+33 481 653 365, marc.fantino@creabio-ra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 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 NCT03526120, 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 16 May 2018.