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CompletedNCT01239147Updated Apr 29, 2013

Effects of Whole Grain on Weight Maintenance

A Phase 3 interventional study of Diet rich in whole grain and Refined grain in Abdominal Fat and Body Weight, sponsored by Cereal Partners Worldwide. Completed at 1 site in France. Open to female participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-29.

Sponsored by Cereal Partners Worldwide · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Female
01

Study summary

Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Furthermore, prospective cohort studies suggest that people with high whole grain consumption have less risk for body weight gain compared with low whole grain consumption.

The purpose of this study is to assess the effects of inclusion of whole grain in the diet on anthropometric measures, particularly abdominal fat regain after a weight loss diet.

It is anticipated that the short-term regain of abdominal fat after a weight loss diet is lower in volunteers consuming whole grain than in volunteers consuming refined grain.

02

Conditions studied

  • Abdominal Fat
  • Body Weight

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Keywords

  • weight maintenance
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 132 are open to participants now.

This study's enrollment of 186 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

This is the only study on the registry with Cereal Partners Worldwide as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subject, as determined by clinical examination, and medical history,
  • Non-menopausal woman,
  • BMI between 27 and 34 kg/m²
  • Waist circumference > 80 cm.
  • No diet within the last 3 months with weight loss or gain not more than 3kg.
  • Non-smoking subject, or smoking less than 15 cigarettes/day since three months,
  • Normal blood pressure (BP) and heart rate (HR) after 10 minutes in supine position. Individuals values out of the normal range can be accepted if judged clinically non relevant by the investigator.
  • Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
  • Subject with a habitual low (\< 16 g/day) intake of whole grain foods (from cereal food intake questionnaire),
  • willing to eat breakfast cereals
  • no intense physical activity,
  • written consent to participate in the study,
  • covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
  • registered in the national file of volunteers participating in biomedical research,
  • Subject who has lost at least 6% initial body weight after the weight loss diet will be randomized to either the whole grain or the refined grain diet

Exclusion criteria

Exclusion Criteria:

  • Subject having a history of metabolic disease (i.e, diabetes),
  • Subject suffering from chronic renal insufficiency
  • Subject receiving a local or general treatment (i.e, prescription medications, over-the-counter medications, dietary supplements or herbal supplements) susceptible to interfere with the evaluation of the studied parameters and in particular weight (eg, appetite suppressants, slimming or treatment which could interfere with the metabolism and dietary behaviour),
  • Subject with ongoing medication not stabilized since more than 3 months,
  • Subject having had a general anaesthesia in the month preceding inclusion, or gastro-intestinal surgery at any time in his/her life, with the possible exception of appendectomy,
  • Pregnant or breast-feeding subject (positive urinary pregnancy test),
  • Subject in an exclusion period of a previous study or having participated in another clinical study in the last month,
  • Use of laxatives, except in few occasions, if, in the opinion of the investigator, does not interfere with the optimal participation,
  • Subject having received more than 4500 Euros in indemnity for participation in clinical studies in the last 12 months, including participation in the present study,
  • Subject in a situation that, in the opinion of the investigator, could interfere with his optimal participation in the study or constitute a particular risk for the subject,
  • Subject under any administrative or legal supervision.
  • Subjects with known allergies to cereals
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (actual)

Study arms

  • Other
    Whole grain diet

    Other: Diet rich in whole grain

  • Other
    Refined grain diet

    Other: Refined grain

Interventions

  • OtherDiet rich in whole grain

    Ready-to-eat breakfast cereals and other cereal products, rich in whole grain

  • OtherRefined grain

    Ready-to-eat breakfast cereals and other cereal products, low in whole grain

06

What researchers measure

Primary outcomes

  1. Abdominal fat

    Abdominal fat mass (DEXA)

    Time frame: 12 weeks

Secondary outcomes

  1. Body composition

    Body composition (DEXA

    Time frame: 12 weeks

  2. body weight

    body weight (kg)

    Time frame: 12 weeks

07

Study locations

1 site
  • Optimed Clinical Research
    Gieres, 38610, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01239147
Lead sponsor
Cereal Partners Worldwide
Responsible party
Sponsor
First posted
Nov 11, 2010
Start date
Oct 2010
Primary completion
Sep 2012
Completion
Apr 2013
Last update
Apr 29, 2013

Study contacts

Yves DONAZZOLO, MD, MSc
principal investigator · Optimed Clinical Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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