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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Diseases; Cardiovascular Diseases; Obesity
• Intervention / Treatment: Other: Refined wheat; Other: Wholegrain wheat; Other: Wholegrain rye

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Refined wheat; Refined wheat grain, a variety of cereal foods providing no wholegrain	Other: Refined wheat; A variety of cereal foods providing 0g/day wholegrain
Experimental: Wholegrain wheat; Wholegrain wheat grain, a variety of cereal foods providing >100g wheat wholegrain/day	Other: Wholegrain wheat; A variety of cereal foods providing >100g/day wholegrain from wheat
Experimental: Wholegrain rye; Wholegrain rye grain, a variety of cereal foods providing >100g rye wholegrain/day	Other: Wholegrain rye; A variety of cereal foods providing >100g/day wholegrain from rye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood pressure	Diastolic and systolic blood pressure and heart rate assessed twice using an automated apparatus	Change from 0 to 6 weeks
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
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
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
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
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
Short chain fatty acids, fecal concentrations of short chain fatty acids	Fecal concentrations of short chain fatty acids	Change from 0 to 6 weeks
Fecal pH	Fecal pH assessed in homogenized fecal sample	Change from 0 to 6 weeks
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
Zonulin, fasting concentrations in plasma	Fasting concentrations of zonulin in plasma	Change from 0 to 6 weeks
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
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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Lantmännens Forskningsstiftelse

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: H-1-2014-062