Effects of Whole Grain on Weight Maintenance

NCT01239147 | Completed Phase 3 DMC

• 1 other identifier: 2009.02.CPW / OP71709.UPC.CPW
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Fat; Body Weight

Keywords

weight maintenance

Outcome Measures

Primary Outcomes (1)

• Abdominal fat

  Abdominal fat mass (DEXA)

  12 weeks

Secondary Outcomes (2)

• Body composition

  12 weeks

• body weight

  12 weeks

Study Arms (2)

Whole grain diet

OTHER

Other: Diet rich in whole grain

Refined grain diet

OTHER

Other: Refined grain

Interventions

Diet rich in whole grain OTHER

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

Whole grain diet

Refined grain OTHER

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

Refined grain diet

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,
• Pregnant or breast-feeding subject (positive urinary pregnancy test),
• 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

Sponsors & Collaborators

• Cereal Partners Worldwide: lead

Study Sites (1)

Optimed Clinical Research

Gières, 38610, France

Location

MeSH Terms

Conditions

Body Weight

Interventions

Whole Grains

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Edible Grain; Crops, Agricultural; Food; Diet, Food, and Nutrition; Physiological Phenomena; Seeds; Food and Beverages

Study Officials

• Yves DONAZZOLO, MD, MSc

  Optimed Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 11, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

FR (1)