NCT02449148

Brief Summary

This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2015

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

April 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

April 1, 2015

Last Update Submit

December 27, 2021

Conditions

ObesityVisceral ObesityWeight LossMetabolic DiseasesBody Composition, Beneficial

Keywords

energy restrictionfastingintermittent fastcancer preventionsubcutaneous fat tissue gene expression

Outcome Measures

Primary Outcomes (1)

  • Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing

    Assessments at baseline (week 0), and after the intervention phase (week 13)

Secondary Outcomes (10)

  • Changes in abdominal fat distribution pattern (visceral, subcutaneous, total adipose tissue) measured by magnetic resonance spectroscopy

    Assessments at baseline (week 0), after the intervention phase (week 13),and after the follow-up phase (week 52)

  • Changes in blood-based biomarkers, i.e. parameters of inflammation, adipokines, growth and hormonal factors, which have been shown to be associated with obesity-related chronic diseases before

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintenance phase (week 25), and after the maintenance phase (week 25)

  • Changes in weight (kg)

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52)

  • Changes in BMI (kg/m2)

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52)

  • Changes in waist circumference (cm)

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52)

  • +5 more secondary outcomes

Other Outcomes (2)

  • Changes in the composition of the gut microbiota by taxonomic, functional, and comparative analysis of sequencing data

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52)

  • Changes in blood metabolites, as measured by LC-MS/MS-based targeted and untargeted metabolomics tools

    Assessments at baseline (week 0), after the intervention phase (week 13), after the maintencance phase (week 25) and after the follow-up phase (week 52)

Study Arms (3)

Intermittent Calorie Restriction

EXPERIMENTAL

2 days per week fasting with 25 % energy intake and 5 days per week at 100% energy intake

Other: Calorie Restriction

Continuous Calorie Restriction

EXPERIMENTAL

daily energy intake of 80 %

Other: Calorie Restriction

Healthy Nutrition

NO INTERVENTION

general advice on healthy nutrition

Interventions

Calorie RestrictionOTHER

diet intervention to reduce the risk for obesity associated diseases

Also known as: weight loss trial;
Continuous Calorie RestrictionIntermittent Calorie Restriction

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men aged 35 to 65 years
  • Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 )
  • German speaking
  • Non- smoker
  • Provision of written informed consent

You may not qualify if:

  • Not able to understand and sign the informed consent form in person
  • Already diagnosed diabetes
  • HbA1c ≥ 6.5 % and/or fasting plasma glucose \> 125 mg/dl
  • History of cancer within the past 10 years
  • Risk of bleeding disorders (e.g. Marcumar intake)
  • Current or history of eating disorders (bulimia, anorexia, binge-eating)
  • Pregnant or lactating during the past 12 months
  • Increased or decreased thyroid-stimulating hormone in baseline blood check
  • Already diagnosed hepatic dysfunction and/or increased or decreased γ-GT, GPT and/or GOT in baseline blood check
  • Already diagnosed kidney dysfunction and/or increased or decreased creatinine, urea and/or uric acid in baseline blood check
  • Medications that might affect the endpoints of the study e.g. immunosuppressive medication (cortisol, antibody treatment), hormone replacement therapy, medication for fat metabolism (e.g. statine, fibrate)
  • Participation in another intervention study shorter than three months ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, Baden-Wurttemberg, D-69120, Germany

Location

Related Publications (3)

  • Sowah SA, Milanese A, Schubel R, Wirbel J, Kartal E, Johnson TS, Hirche F, Grafetstatter M, Nonnenmacher T, Kirsten R, Lopez-Nogueroles M, Lahoz A, Schwarz KV, Okun JG, Ulrich CM, Nattenmuller J, von Eckardstein A, Muller D, Stangl GI, Kaaks R, Kuhn T, Zeller G. Calorie restriction improves metabolic state independently of gut microbiome composition: a randomized dietary intervention trial. Genome Med. 2022 Mar 14;14(1):30. doi: 10.1186/s13073-022-01030-0.

    PMID: 35287713DERIVED

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

  • Schubel R, Nattenmuller J, Sookthai D, Nonnenmacher T, Graf ME, Riedl L, Schlett CL, von Stackelberg O, Johnson T, Nabers D, Kirsten R, Kratz M, Kauczor HU, Ulrich CM, Kaaks R, Kuhn T. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):933-945. doi: 10.1093/ajcn/nqy196.

    PMID: 30475957DERIVED

MeSH Terms

Conditions

ObesityObesity, AbdominalWeight LossMetabolic DiseasesGlucocorticoid Receptor DeficiencyFasting

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Tilman Kühn, PhD

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Tilman Kühn

Study Record Dates

First Submitted

April 1, 2015

First Posted

May 20, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

DE(1)