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Effects of Whole Grain on Weight Maintenance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cereal Partners Worldwide
ClinicalTrials.gov Identifier:
NCT01239147
First received: October 27, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Abdominal Fat
Body Weight
Other: Diet rich in whole grain
Other: Refined grain
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Whole Grain Inclusion in the Diet on Abdominal Fat Regain After a Weight Loss Diet

Resource links provided by NLM:


Further study details as provided by Cereal Partners Worldwide:

Primary Outcome Measures:
  • Abdominal fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Abdominal fat mass (DEXA)


Secondary Outcome Measures:
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body composition (DEXA

  • body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    body weight (kg)


Enrollment: 186
Study Start Date: October 2010
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Whole grain diet Other: Diet rich in whole grain
Ready-to-eat breakfast cereals and other cereal products, rich in whole grain
Refined grain diet Other: Refined grain
Ready-to-eat breakfast cereals and other cereal products, low in whole grain

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239147

Locations
France
Optimed Clinical Research
Gieres, France, 38610
Sponsors and Collaborators
Cereal Partners Worldwide
Investigators
Principal Investigator: Yves DONAZZOLO, MD, MSc Optimed Clinical Research
  More Information

No publications provided

Responsible Party: Cereal Partners Worldwide
ClinicalTrials.gov Identifier: NCT01239147     History of Changes
Obsolete Identifiers: NCT01848405
Other Study ID Numbers: 2009.02.CPW / OP71709.UPC.CPW
Study First Received: October 27, 2010
Last Updated: April 26, 2013
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante

Keywords provided by Cereal Partners Worldwide:
weight maintenance

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014