NCT03526120

Brief 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 daily energy intake, and improve diet quality, anthropometry and body composition.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

April 22, 2018

Last Update Submit

May 3, 2018

Conditions

Healthy

Keywords

Human subjectsPistachio snackBody mass indexEnergy intakeFat mass

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Body weight in kg

    12 weeks

Secondary Outcomes (4)

  • Total daily energy intake

    12 weeks

  • Appetite ratings

    12 weeks

  • Body weight index

    12 weeks

  • Body fat mass

    12 weeks

Study Arms (2)

Pistachio diet

EXPERIMENTAL

Incorporates 44 g (1 serving) of pistachios into a daily diet

Other: Pistachio

Control

NO INTERVENTION

No pistachio consumption

Interventions

PistachioOTHER

Dailly 44 g unsalted pistachios snack for 12 weeks

Pistachio diet

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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);
  • 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

You may not qualify if:

  • 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;
  • 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 €).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CreaBio Rhône-Alpes

Givors, Rhône, F-69700, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31604062DERIVED

Study Officials

  • Marc FANTINO, MD, PhD, Pr.

    CreaBio Rhône-Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc FANTINO, MD, PhD, Pr.

CONTACT

+33 481 653 365marc.fantino@creabio-ra.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

April 22, 2018

First Posted

May 16, 2018

Study Start

February 27, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)