NCT04100356

Brief Summary

The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2014

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2014

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

September 13, 2019

Last Update Submit

November 26, 2020

Conditions

Overweight and Obesity

Keywords

Low-carbohydrate-high-fat diet (LCHF)Low-density-lipoprotein (LDL)High-density-lipoprotein (HDL)Triglycerides (TG)LipidsGlucose tolerance (GT)Insulin resistance (IR)Body compositionWeight

Outcome Measures

Primary Outcomes (1)

  • Area under curve (AUC) glucose

    AUC glucose measured during an OGTT

    Change from baseline AUC glucose at 10 weeks

Secondary Outcomes (3)

  • Lipid profile

    Change from Baseline lipids at 10 weeks

  • Body composition

    Change from baseline values at 10 weeks

  • Cardiorespiratory fitness

    Change from baseline values at 10 weeks

Study Arms (4)

Normal diet

EXPERIMENTAL

The group ingests normal diet, recommended by the health authorities

Other: Normal Diet

LCHF diet

EXPERIMENTAL

The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat

Other: LCHF Diet

Normal diet + exercise

EXPERIMENTAL

The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week.

Other: ExerciseOther: Normal Diet

LCHF diet + exercise

EXPERIMENTAL

The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week.

Other: ExerciseOther: LCHF Diet

Interventions

ExerciseOTHER

Exercise program - indoor bicycle interval exercise, duration 60 min 3x week

LCHF diet + exerciseNormal diet + exercise
Normal DietOTHER

Normal diet recommended by the health authorities

Normal dietNormal diet + exercise
LCHF DietOTHER

LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates

LCHF dietLCHF diet + exercise

Eligibility Criteria

Age33 Years - 47 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • Sedentary
  • Premenopausal
  • Caucasian
  • BMI 26.9 - 36.1
  • Age 33-4
  • Living close to, or in Oslo.

You may not qualify if:

  • Pregnancy
  • Breast-feeding
  • Smoking or tobacco use
  • Previous medical history of cardio-vascular disease (CVD)
  • Previous medical history of diabetes
  • Previous medical history of endocrine disorder
  • Previous medical history of kidney disease
  • Use of lipid lowering medication
  • Use of diabetes medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sports Sciences

Oslo, 0863, Norway

Location

Related Publications (1)

  • Valsdottir TD, Ovrebo B, Kornfeldt TM, Litleskare S, Johansen EI, Henriksen C, Jensen J. Effect of aerobic exercise and low-carbohydrate high-fat diet on glucose tolerance and android/gynoid fat in overweight/obese women: A randomized controlled trial. Front Physiol. 2023 Jan 24;14:1056296. doi: 10.3389/fphys.2023.1056296. eCollection 2023.

    PMID: 36760521DERIVED

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceBody Weight

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jørgen Jensen, Professor

    Norwegian School of Sport Sciences, Section of Physical Performance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Diet and exercise, or diet only
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 24, 2019

Study Start

January 21, 2014

Primary Completion

April 4, 2014

Study Completion

April 23, 2014

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)