The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response

NCT02405507 | Completed Phase 2

• 1 other identifier: VI001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Wheat germ is a by-product of the wheat-milling industry with high nutritional value and therefore could be used as a raw source for the preparation of food products such as bread, cookies, muffins, etc. The aim of this study is to assess the effects of ingesting wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

Conditions

Healthy Volunteers

Keywords

Gastrointestinal Discomfort; Wheat germ; Constipation; Glycaemic Index; Blood Cholesterol Level; Glycaemic Response; Cholesterol; PAC-SYM; Gut Microbiota

Outcome Measures

Primary Outcomes (7)

• Changes in mean Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to weeks 2, 4, 7, 9, 11 and 13

  A validated PAC-SYM questionnaire will be used. PAC-SYM is a 12-item, self-administered questionnaire used to measure severity of symptoms over the past 2 weeks in patients with constipation. The PAC-SYM questionnaire has been demonstrated and documented to have internal consistency, reproducibility, validity, sensitivity, and responsiveness. PAC-SYM items are rated on a 5-point scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe) and grouped into three subscales related to abdominal symptoms (bloating, discomfort, pain, and cramps), stool symptoms (incomplete bowel movement, false alarm, straining, too hard, and too small), and rectal symptoms (painful bowel movement, burning, and bleeding or tearing). The total score and subscale scores are computed by taking the mean of item responses (score range 0-4). A reduction in score reflects an improvement in symptoms. Cultural adaptation and linguistic validation of the PAC-SYM for Portugal was performed by Mapi Research.

  at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover)

• Changes in fasting serum total cholesterol from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)

• Changes in fasting serum triglycerides from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)

• Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)

• Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)

• Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)

• Changes in capillary blood glucose from baseline to visit 2 and 4

  0, 30, 60 and 120 minutes post-meal: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)

Secondary Outcomes (7)

• Changes in mean Patient Assessment of Constipation Quality of Life (PAC-QOL) score from baseline to weeks 2, 4, 7, 9, 11 and 13

  at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover)

• Changes in intestinal microbiota from baseline to visit 2, 3 and 4

  at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period), and visit 4 (after 4-week intake period after crossover)

• Changes in mean daily abdominal discomfort score from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13

  daily during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period (weeks 5, 6, 7, 8 and 9)

• Changes in stool consistency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13

  at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9)

• Changes in stool frequency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13

  at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9)

Other Outcomes (1)

• Adverse events

  at visit 2 (after 4-week intake period), visit 3 (after 5-week washout period), and visit 4 (after 4-week intake period after crossover)

Study Arms (2)

wheat bread with wheat germ

EXPERIMENTAL

wheat bread with wheat germ supplementation

Dietary Supplement: wheat bread with wheat germ

wheat bread without wheat germ

PLACEBO COMPARATOR

wheat bread without wheat germ supplementation

Dietary Supplement: wheat bread without wheat germ

Interventions

wheat bread with wheat germ DIETARY_SUPPLEMENT

wheat bread with wheat germ

wheat bread without wheat germ DIETARY_SUPPLEMENT

wheat bread without wheat germ

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men or women
• Age 18 - 60 years
• Healthy volunteers free of chronic diseases with relevant effect on the gastrointestinal system or on visceral motility
• Without a diagnosis of any digestive disease including functional bowel disorders such as IBS
• Non-diabetic, no gastric bypass surgery
• Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
• Non-smoker
• Willing and able to provide written informed consent

You may not qualify if:

• Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
• Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
• Subjects with stool frequency of ≤ 1 stool every 7 days
• Subjects not willing to avoid pre- and probiotics for the duration of the study
• Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
• Current use of medication for lowering blood cholesterol or glucose
• Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibres)
• Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject
• Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study
• Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
• Known food intolerance or allergy
• Subject involved in any clinical or food study within the preceding month

Sponsors & Collaborators

• Universidade do Porto: lead
• Center for Health Technology and Services Research: collaborator
• Project VALORINTEGRADOR financed by COMPETE (FCOMP-01-0202-FEDER-038861): collaborator

Study Sites (2)

PtCRIN

Lisbon, Portugal

Location

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

Related Publications (3)

• Moreira-Rosario A, Marques C, Pinheiro H, Norberto S, Sintra D, Teixeira JA, Calhau C, Azevedo LF. Daily intake of wheat germ-enriched bread may promote a healthy gut bacterial microbiota: a randomised controlled trial. Eur J Nutr. 2020 Aug;59(5):1951-1961. doi: 10.1007/s00394-019-02045-x. Epub 2019 Jul 19.

  PMID: 31325040 RESULT

• Moreira-Rosario A, Pinheiro H, Marques C, Teixeira JA, Calhau C, Azevedo LF. Does intake of bread supplemented with wheat germ have a preventive role on cardiovascular disease risk markers in healthy volunteers? A randomised, controlled, crossover trial. BMJ Open. 2019 Jan 17;9(1):e023662. doi: 10.1136/bmjopen-2018-023662.

  PMID: 30659039 RESULT

• Moreira-Rosario A, Pinheiro H, Calhau C, Azevedo LF. Can wheat germ have a beneficial effect on human health? A study protocol for a randomised crossover controlled trial to evaluate its health effects. BMJ Open. 2016 Nov 10;6(11):e013098. doi: 10.1136/bmjopen-2016-013098.

  PMID: 28157671 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Conceição Calhau, PhD

  CINTESIS, Faculty of Medicine of the University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 1, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 7, 2019

Record last verified: 2017-05

Locations

PT (2)