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

NCT02358122 | Unknown

• 1 other identifier: H-1-2014-062
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastrointestinal Diseases; Cardiovascular Diseases; Obesity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (13)

• Anthropometric masures

  Change from 0 to 6 weeks

• Blood pressure

  Change from 0 to 6 weeks

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

  Change from 0 to 6 weeks

• Glucose metabolism, fasting concentrations of glucose, insulin and HbA1C as calculation of HOMA-IR

  Change from 0 to 6 weeks

• Low-grade inflammation, fasting concentrations of hsCRP, IL-6, IL-10, and TNF-a

  Change from 0 to 6 weeks

Study Arms (3)

Refined wheat

ACTIVE COMPARATOR

Refined wheat grain, a variety of cereal foods providing no wholegrain

Other: Refined wheat

Wholegrain wheat

EXPERIMENTAL

Wholegrain wheat grain, a variety of cereal foods providing \>100g wheat wholegrain/day

Other: Wholegrain wheat

Wholegrain rye

EXPERIMENTAL

Wholegrain rye grain, a variety of cereal foods providing \>100g rye wholegrain/day

Other: Wholegrain rye

Interventions

Wholegrain rye OTHER

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

Wholegrain rye

Wholegrain wheat OTHER

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

Wholegrain wheat

Refined wheat OTHER

A variety of cereal foods providing 0g/day wholegrain

Refined wheat

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Lantmännens Forskningsstiftelse: collaborator

Related Publications (3)

• 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.

  PMID: 31504699 DERIVED

• 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.

  PMID: 28954842 DERIVED

• 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.

  PMID: 28327566 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 6, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 6, 2015

Record last verified: 2015-02