High Fiber Rye Foods for Body Weight and Body Fat Reduction

NCT04203758 | Completed

• 1 other identifier: RW2
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Investigate if there is a difference in body weight at week 12

  Measured on a scale

  12 weeks

• Investigate if there is a difference in body fat mass at week 12

  Measured by dual energy x-ray absorptiometry

  12 weeks

Secondary Outcomes (16)

• Investigate if there are differences in subjective appetite ratings

  0 weeks, 6 weeks and 12 weeks.

• Investigate if differences in primary endpoints (body weight) are apparent at week 6

  6 weeks

• Investigate if differences in primary endpoints (fat mass) are apparent at week 6

  6 weeks

• Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention

  6 weeks and 12 weeks

• Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention

  6 weeks and 12 weeks

Study Arms (2)

Wholegrain rye products with a high content of dietary fiber

EXPERIMENTAL

Cereal products based on wholegrain rye

Other: Cereal products based on rye

Refined wheat products with a low content of dietary fiber

ACTIVE COMPARATOR

Cereal products based on refined wheat

Other: Cereal products based on wheat

Interventions

Cereal products based on rye OTHER

Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.

Wholegrain rye products with a high content of dietary fiber

Cereal products based on wheat OTHER

Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

Refined wheat products with a low content of dietary fiber

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Age 30-70 y
• BMI 27-35 kg/m2
• Hemoglobin ≥117g/l for women and for men ≥134g/l
• Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
• Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
• Triglycerides ≤2.60 mmol/L
• Signed informed consent

You may not qualify if:

• Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
• Unable to satisfactorily complete the 3-day weighted food record between screening visits.
• Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period
• Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
• Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
• Using e-cigarettes (regardless of nicotine content)
• Following any weight reduction program or having followed one during the last 6 months prior to visit 1.
• Diastolic blood pressure 105 mmHg or more at visit 1
• Systolic blood pressure 160 mmHg or more at visit 1
• History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
• More than 10 hours physical activity per week
• History of heart failure or heart attack within 1 year prior to screening
• Having type I diabetes
• Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
• Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.

Sponsors & Collaborators

• Chalmers University of Technology: lead

Study Sites (1)

Chalmers University of Technology

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Rikard Landberg, PhD

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: January 20, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)