Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02358122
Other study ID # H-1-2014-062
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2