Bread Related Effect on MicrobiAl Distribution (BREAD) Study.

Not Applicable

Completed

• Conditions: ow fibre intake; Low fibre intake; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12622000884707
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-22
• Study Completion: 2022-12-22
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1) Low baseline intake of dietary fibre i.e. Males: under 22 g/day and females under 18 g/day
2) No history of bowel disease
3) Non-smokers
4) Not on fibre supplement consumption during the last month prior screening
5) Regular bread consumption
6) Adults (18-65)
7) Good general health
8) A body mass index (BMI) between 18 and 35.

Exclusion Criteria

1.Inability to give informed consent
2.Indication of inability to comply with study procedures
3.Antibiotic use within the last month
4.Hypersensitivity to wheat or rice
5.Pregnant, breastfeeding, or planning a pregnancy in the three months post selection/during (study period)
6.Alarm features associated with bowel habits such as recent changes in bowel habits (onset < three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of gastrointestinal cancer at an early age
7.Known significant gut disorder and disease: Chronic constipation or diarrhoea, irritable bowel syndrome (IBS), Inflammatory Bowel Disease (IBD), diverticulitis, coeliac disease, or previous bowel resection
8.Chronic disease such as cardiovascular disease, cancer, renal failure, previous upper or lower GI surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke
9.Known systemic conditions (heart disease, kidney disease, diabetes, metabolic syndrome, psychological disorder) that could influence the gut directly or through medication use such as diabetes, opiate, or non-steroidal anti-inflammatory drugs use)
10.Fasting blood glucose less than or equal to 6.0 mmol/L
11.Laxative, pre- and probiotic use, and inability or unwillingness to stop using for the seven days before sample collections.

Non-exclusion Criteria
Diagnosed and stable systemic conditions for more than three months.
The use of selective serotonin reuptake inhibitors, tricyclics, or NSAIDs will be permitted if the medication has been used continually and the condition has been stable for more than three months.
Stable and controlled diabetes for more than three months
Inability to swallow capsules (for the ATMO sub study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified