NCT04248673

Brief Summary

The hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

January 22, 2020

Last Update Submit

October 27, 2021

Conditions

Body Weight

Outcome Measures

Primary Outcomes (1)

  • body weight

    change of body weight in kg

    3 months

Secondary Outcomes (14)

  • body mass index

    3 months

  • waist circumference

    3 months

  • waist-to-height-index

    3 months

  • hip circumference

    3 months

  • blood pressure

    3 months

  • +9 more secondary outcomes

Study Arms (2)

carbohydrate rich bread

PLACEBO COMPARATOR
Other: carbohydrate rich bread

carbohydrate reduced bread

EXPERIMENTAL
Other: carbohydrate reduced bread

Interventions

carbohydrate reduced breadOTHER

Consumption of carbohydrate reduced bread for three months.

carbohydrate reduced bread
carbohydrate rich breadOTHER

Consumption of carbohydrate rich bread for three months.

carbohydrate rich bread

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- body mass index of at least 27 kg/m2

You may not qualify if:

  • serious illness with hospitalization in the last 3 months
  • Changes in body weight (estimated weekly average) by more than 2 kg in the past 4 weeks
  • Non-smoking status for less than 3 months
  • Change of smoking habits planned during the study
  • acute diseases such as respiratory or gastrointestinal infections
  • Chronic diseases, e.g. Tumor diseases, chronic obstructive pulmonary disease (COPD), asthma, dementia, intestinal diseases, diabetes
  • regular use of medication (except contraceptives) such as Lipid lowering, blood pressure lowering, weight-regulating medication, aspirin
  • no contraception in women of childbearing age or breastfeeding a child
  • high sporting activity (≥ 1 hour per day)
  • planned absence of\> 7 days during the intervention phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 30, 2020

Study Start

August 1, 2020

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)