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Completed

NCT Number: NCT03875898

Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact

The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)

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Key information

Conditions

Healthy Obesity, Metabolically Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Metabolically Benign Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index of 25 to 35 kg/m2
  • Waist circumference greater than 80 cm for women and than 96 cm for men
  • Low level of fibre intake (<20 g /d) and low level of fibre nature diversity
  • Daily bread consumption

Exclusion criteria

  • Bread products allergy or intolerance
  • Digestive surgery history except appendicectomy
  • Metabolic or gastrointestinal disease history
  • Medication that could interfere with glucose and lipid metabolism or intestinal microbiota (for example, no antibiotics within the 3 months before the study)
  • Smokers (5 cig/d or more)

Treatment and study plan

150 g bread fortified (15 g mix fibre)

Other

Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.

150 g unfortified bread

Other

Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks

Primary outcomes

  1. Change from Baseline Intestinal microbiota composition at eight weeks

    Time frame: baseline and eight weeks

    intestinal microbiota composition will be measured by metagenomic analysis before all interventions, and before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

Secondary outcomes

  1. Change from baseline fasting and post prandial plasma glucose at eight weeks

    Time frame: baseline and eight weeks

    Plasma glucose will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  2. Change from baseline fasting and post prandial plasma Insulin at eight weeks

    Time frame: baseline and eight weeks

    Plasma insulin will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  3. Change from baseline fasting and post prandial plasma triglycerides at eight weeks

    Time frame: baseline and eight weeks

    Plasma triglycerides will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  4. Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks

    Time frame: baseline and eight weeks

    Plasma non-esterified fatty acids will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  5. Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks

    Time frame: baseline and eight weeks

    Fasting plasma lipids will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  6. Change from baseline C-Reactive Protein at eight weeks

    Time frame: baseline and eight weeks

    CRPus will be measured before and after each eight weeks, consumption sequences (fiber-fortified bread vs unfortified)

  7. Change from baseline MDA (Malon Di Aldehyde) at eight weeks

    Time frame: baseline and eight weeks

    MDA will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  8. Change from baseline Acetylated ghrelin at eight weeks

    Time frame: baseline and eight weeks

    Acylated ghrelin will be measured in the fasting state and postprandial period (at 0 and 240 min) before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  9. Change from baseline Satiety evaluation at eight weeks

    Time frame: baseline and eight weeks

    Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS) (on a 90mm horizontal line; from no sensation of satiety (minimal) to strong sensation of satiety (maximum).

  10. Change from baseline Body composition at eight weeks

    Time frame: baseline and eight weeks

    Body composition will be measured with bio-impedancemetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  11. Change from Baseline Resting Energy Expenditure at eight weeks

    Time frame: baseline and eight weeks

    Resting Energy Expenditure will be measured with indirect calorimetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified).

  12. Change from Baseline substrate oxydation at eight weeks

    Time frame: baseline and eight weeks

    Substrate oxydation (in the postprandial period over 7 hours) will be measured with indirect calorimetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified).

  13. Change from baseline fibre intake at eight weeks

    Time frame: baseline and eight weeks

    The volunteers will complete a dietary survey of three days and fibre questionnaire

  14. Change from baseline Gastrointestinal tolerance symptoms at eight weeks.

    Time frame: baseline and eight weeks

    Subjective ratings of bloating, nausea, vomiting, abdominal cramping and flatulence will be measured using visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).

  15. Change from baseline stool consistency at eight weeks

    Time frame: baseline and eight weeks

    Stool consistency by Bristol Stool Chart (type1-7)

Sponsors and collaborators

Lead sponsor

Bridor

Industry

Registry information

Official study title

Study of the Impact of Daily Bread Consumption Enriched With a Fibre Mix on Intestinal Microbiota and Metabolic Profile in Subjects at Metabolic Risk

Acronym: Breath

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2019
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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