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AzTrials

Gastrointestinal DiseasesRIGHTNCT02358122

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

A study testing Wholegrain rye, Wholegrain wheat and Refined wheat in people with Gastrointestinal Diseases and Cardiovascular Diseases, run by University of Copenhagen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
What is being tested?
Wholegrain rye, Wholegrain wheat and Refined wheat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
Sep 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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

About this study

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.

Read the detailed 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.

Being tested
Wholegrain rye, Wholegrain wheat, Refined wheat
Medical subject headings
Gastrointestinal Diseases, Cardiovascular Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wholegrain ryeOther

    A variety of cereal foods providing >100g/day wholegrain from rye

  • Wholegrain wheatOther

    A variety of cereal foods providing >100g/day wholegrain from wheat

  • Refined wheatOther

    A variety of cereal foods providing 0g/day wholegrain

Study groups in NCT02358122
Study groupRoleWhat they receive
Refined wheatActive comparatorRefined wheat grain, a variety of cereal foods providing no wholegrain
Receives: Other: Refined wheat
Wholegrain wheatExperimentalWholegrain wheat grain, a variety of cereal foods providing >100g wheat wholegrain/day
Receives: Other: Wholegrain wheat
Wholegrain ryeExperimentalWholegrain rye grain, a variety of cereal foods providing >100g rye wholegrain/day
Receives: Other: Wholegrain rye

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)

    Subjective sensations of gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales)

    Measured: Change from 0 to 6 weeks

  2. Gut microbiota composition assessed using 16S in a single fecal sample

    Gut microbiota compostion assessed using 16S in a single fecal sample

    Measured: Change from 0 to 6 weeks

Secondary outcomes (13)

  1. Anthropometric masures

    Body weight and waist circumference, saggital abdominal diameter and body composition (fat mass and fat free mass assessed using DEXA)

    Measured: Change from 0 to 6 weeks

  2. Blood pressure

    Diastolic and systolic blood pressure and heart rate assessed twice using an automated apparatus

    Measured: Change from 0 to 6 weeks

  3. Blood lipids, fasting concentrations of total, LDL and HDL cholesterol and triglyerides

    Fasting concentrations of total, LDL and HDL cholesterol and triglyerides

    Measured: Change from 0 to 6 weeks

  4. 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

    Measured: Change from 0 to 6 weeks

  5. 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

    Measured: Change from 0 to 6 weeks

  6. Appetite sensation

    Fasting and postprandial (every 30 minutes for 240 minutes) sensation of hunger, satiety, fullness, prospective food intake, thirst and well being

    Measured: Change from 0 to 6 weeks

  7. 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

    Measured: Change from 0 to 6 weeks

  8. Short chain fatty acids, fecal concentrations of short chain fatty acids

    Fecal concentrations of short chain fatty acids

    Measured: Change from 0 to 6 weeks

  9. Fecal pH

    Fecal pH assessed in homogenized fecal sample

    Measured: Change from 0 to 6 weeks

  10. 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

    Measured: Change from 0 to 6 weeks

  11. Zonulin, fasting concentrations in plasma

    Fasting concentrations of zonulin in plasma

    Measured: Change from 0 to 6 weeks

  12. 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

    Measured: Change from 0 to 6 weeks

  13. 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

    Measured: Change from 0 to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2014
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02358122
Sponsor's protocol ID
H-1-2014-062
Acronym
RIGHT
Status last verified
Feb 2015
First submitted
21 Jan 2015
Last updated
6 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Christensen L, Vuholm S, Roager HM, Nielsen DS, Krych L, Kristensen M, Astrup A, Hjorth MF. Prevotella Abundance Predicts Weight Loss Success in Healthy, Overweight Adults Consuming a Whole-Grain Diet Ad Libitum: A Post Hoc Analysis of a 6-Wk Randomized Controlled Trial. J Nutr. 2019 Dec 1;149(12):2174-2181. doi: 10.1093/jn/nxz198.

    PubMed 31504699

  • Vuholm S, Nielsen DS, Iversen KN, Suhr J, Westermann P, Krych L, Andersen JR, Kristensen M. Whole-Grain Rye and Wheat Affect Some Markers of Gut Health without Altering the Fecal Microbiota in Healthy Overweight Adults: A 6-Week Randomized Trial. J Nutr. 2017 Nov;147(11):2067-2075. doi: 10.3945/jn.117.250647. Epub 2017 Sep 27.

    PubMed 28954842

  • Suhr J, Vuholm S, Iversen KN, Landberg R, Kristensen M. Wholegrain rye, but not wholegrain wheat, lowers body weight and fat mass compared with refined wheat: a 6-week randomized study. Eur J Clin Nutr. 2017 Aug;71(8):959-967. doi: 10.1038/ejcn.2017.12. Epub 2017 Mar 22.

    PubMed 28327566

Questions about this trial

What is this clinical trial studying?

A study testing Wholegrain rye, Wholegrain wheat and Refined wheat in people with Gastrointestinal Diseases and Cardiovascular Diseases, run by University of Copenhagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal symptoms evaluated by questionnaires (100mm visual analogue scales) (time frame: Change from 0 to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02358122, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.

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