The Effect of Exercise and/or Diet on Health Related Parameters

NCT ID: NCT04100356

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-21

Study Completion Date

2014-04-23

Brief Summary

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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.

Detailed Description

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Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.

Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.

We wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.

Conditions

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Overweight and Obesity

Keywords

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Low-carbohydrate-high-fat diet (LCHF) Low-density-lipoprotein (LDL) High-density-lipoprotein (HDL) Triglycerides (TG) Lipids Glucose tolerance (GT) Insulin resistance (IR) Body composition Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Diet and exercise, or diet only
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Normal diet

The group ingests normal diet, recommended by the health authorities

Group Type EXPERIMENTAL

Normal Diet

Intervention Type OTHER

Normal diet recommended by the health authorities

LCHF diet

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

Group Type EXPERIMENTAL

LCHF Diet

Intervention Type OTHER

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

Normal diet + exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Normal Diet

Intervention Type OTHER

Normal diet recommended by the health authorities

LCHF diet + exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

LCHF Diet

Intervention Type OTHER

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

Interventions

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Exercise

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

Intervention Type OTHER

Normal Diet

Normal diet recommended by the health authorities

Intervention Type OTHER

LCHF Diet

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

33 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

Atlantis Medical University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jørgen Jensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Norwegian School of Sport Sciences, Section of Physical Performance

Locations

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Norwegian School of Sports Sciences

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 36760521 (View on PubMed)

Other Identifiers

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AMUC-NIH-LCHF-P3-2014

Identifier Type: -

Identifier Source: org_study_id