NCT04234373

Brief Summary

Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress91%
Jul 2020Dec 2026

First Submitted

Initial submission to the registry

January 9, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6.4 years

First QC Date

January 9, 2020

Last Update Submit

April 28, 2026

Conditions

Glucose IntoleranceObesity

Outcome Measures

Primary Outcomes (1)

  • Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.

    Change from baseline to 6 months

Secondary Outcomes (5)

  • Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry

    Change from baseline to 6 months

  • Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples

    Change from baseline to 6 months

  • Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples

    Change from baseline to 6 months

  • Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI

    Change from baseline to 6 months

  • Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI

    Change from baseline to 6 months

Study Arms (1)

Low Carb dietary Intervention

EXPERIMENTAL
Other: Low Carb diet

Interventions

Low Carb dietOTHER

Low Carb diet (max. 130g carbohydrates/d) for 6 months

Low Carb dietary Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Group A: HEALTHY LEAN CONTROLS
  • Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C \<5.7% and fasting glucose \<5.6 mmol/l
  • Normal eating habits
  • Stable body weight for at least three months
  • Informed Consent as documented by signature
  • Group B: PRE-DIABETIC or DIABETIC OBESE
  • Pre-diabetic/Diabetic obese with a HbA1C \>5.7% and/or fasting glucose \>5.6 mmol/l) and body-mass index \> 30kg/m2, otherwise healthy
  • Normal eating habits
  • Stable body weight for at least three months
  • Informed Consent as documented by signature

You may not qualify if:

  • Group A: HEALTHY LEAN CONTROLS
  • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
  • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
  • Psychiatric illness
  • Alcohol abuse, (smoking allowed)
  • Regular intake of medications, (oral contraceptives allowed)
  • Regular intake of pro- or prebiotics
  • Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
  • Clinically relevant acute or chronic inflammatory disease
  • Pregnancy
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Group B: PRE-DIABETIC or DIABETIC OBESE
  • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
  • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
  • Psychiatric illness
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Clara Research Ltd, St Claraspital Basel

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

Glucose IntoleranceObesity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bettina Wölnerhanssen, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 21, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

CH(1)