Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh

Obesity Clinical Trial

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Official title:

Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02358122
• Other study ID #: H-1-2014-062
• Status: Active, not recruiting
• Phase: N/A
• First received: January 21, 2015
• Last updated: February 3, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

A dietary intervention study designed as a randomized, controlled, parallel intervention of 6-weeks duration. A total of 75 participants will be included in the study and randomly allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye). Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood sampling, dietary assessment and a meal challenge will be done before (week 0) and after (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in concerning satisfaction with diet and gastrointestinal symptoms.

Description:

A dietary intervention study designed as a randomized, controlled, parallel intervention of 6-weeks duration. A total of 75 participants will be included in the study and randomly allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye). The randomization will be stratified according to sex and sex-specific median habitual cereal dietary fibre intake (16g/d for men and 13g/d for women). The randomization will be done by means of a randomization generator of the webpage (http://www.randomization.com). Recruitment and randomization will take place continuously during the study period, and therefore randomization will be done as mixed block randomization.

During the intervention study, participants are instructed to substitute all cereal products (e.g. bread, breakfast cereals, pasta) of their diet with the provided study products. The amount of provided study products will match the average intake of carbohydrate-rich products of the Danish population, which corresponds to ~200g of bread and cereal products per day. The participants will eat the study products in an ad libitum manner and b instructed to avoid other cereals in their diet including cake, biscuits, ready made meals and fast foods with the exception of White rice whis is allowed 1-2 times per week.

Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood sampling, dietary assessment and a meal challenge will be done before (week 0) and after (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in concerning satisfaction with diet and gastrointestinal symptoms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• • Age: 30 - 65 years

• Body mass index (BMI): 25 - 32 kg/m2

• Weight stable (<3 kg weight change during the last 6 months)

• Apparently healthy

• Informed consent signed

• Freezer capacity for 2 weeks bread provision

• Can attend all visits required for the study

Exclusion Criteria:

• • Smoking on a daily basis

• Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study

• Diagnosed with any form of diabetes or CVD

• Reported chronic GI disorders

• Antibiotic treatment 3 month before study start and during the study

• Use of pre- or probiotic 1 month before study start and during the study

• Lack of cooperation and adherence to the protocol

• Use of prescription medication will be evaluated on an individual basis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Digestive System Diseases
• Gastrointestinal Diseases
• Obesity

Intervention

Other:
• Wholegrain rye
A variety of cereal foods providing >100g/day wholegrain from rye
• Wholegrain wheat
A variety of cereal foods providing >100g/day wholegrain from wheat
• Refined wheat
A variety of cereal foods providing 0g/day wholegrain

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Lantmännens Forskningsstiftelse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)	Subjective sensations of gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)	Change from 0 to 6 weeks	No
Primary	Gut microbiota composition assessed using 16S in a single fecal sample	Gut microbiota compostion assessed using 16S in a single fecal sample	Change from 0 to 6 weeks	No
Secondary	Anthropometric masures	Body weight and waist circumference, saggital abdominal diameter and body composition (fat mass and fat free mass assessed using DEXA)	Change from 0 to 6 weeks	No
Secondary	Blood pressure	Diastolic and systolic blood pressure and heart rate assessed twice using an automated apparatus	Change from 0 to 6 weeks	No
Secondary	Blood lipids, fasting concentrations of total, LDL and HDL cholesterol and triglyerides	Fasting concentrations of total, LDL and HDL cholesterol and triglyerides	Change from 0 to 6 weeks	No
Secondary	Glucose metabolism, fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR	Fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR	Change from 0 to 6 weeks	No
Secondary	Low-grade inflammation, fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a	Fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a	Change from 0 to 6 weeks	No
Secondary	Appetite sensation	Fasting and postprandial (every 30 minutes for 240 minutes) sensation of hunger, satiety, fullness, prospective food intake, thirst and well being	Change from 0 to 6 weeks	No
Secondary	Breath hydrogen assessed using a Hydrolyzer	Fasting and postprandial (every 30 minutes for 240 minutes) concentrations of H2 in exhaled breath assessed using a Hydrolyzer	Change from 0 to 6 weeks	No
Secondary	Short chain fatty acids, fecal concentrations of short chain fatty acids	Fecal concentrations of short chain fatty acids	Change from 0 to 6 weeks	No
Secondary	Fecal pH	Fecal pH assessed in homogenized fecal sample	Change from 0 to 6 weeks	No
Secondary	Intestinal permeability, assessed by urinary excretion of lactulose and mannitol	Intestinal permeability is assessed by urinary excretion of lactulose and mannitol for 4 hours and 24 hours following an oral load of 10g lactulose and 2 g mannitol	Change from 0 to 6 weeks	No
Secondary	Zonulin, fasting concentrations in plasma	Fasting concentrations of zonulin in plasma	Change from 0 to 6 weeks	No
Secondary	Dietary intake, a weighted 4-day food record	a weighted 4-day food record will be used to assess energy intake and macronutrient (protein, fat, carbohydrates and dietaru fiber) composition	Change from 0 to 6 weeks	No
Secondary	Compliance, measured by fasting plasma alkylresorcinol concentrations will be used as a biomarker of wholegrain wheat and rye intake	Fasting plasma alkylresorcinol concentrations will be used as a biomarker of wholegrain wheat and rye intake	Change from 0 to 6 weeks	No