NUtriGenomic Analysis in Twins

NCT ID: NCT01631123

Last Updated: 2013-01-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The impact of carbohydrates, proteins and fatty acids as major components of daily nutrition on the development of metabolic illnesses is an objective of numerous clinical studies. However, the effect of an isocaloric diet on metabolism is less investigated and not well understood. This study aims to reveal genetic determinated metabolic responses to an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet in healthy twins. This study generates information for further detailed nutrigenomic analysis. Twins receive an isocaloric diet rich in carbohydrates (55% carbohydrates, 15% protein, 30% fat) with dietary counselling for 5 weeks and afterwards with nutrients supplied for 6 days, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 15% protein, 45% fat) for 6 days with nutrients supplied and for 4 weeks with dietary counselling and again followed by another 6 days when nutrients were supplied. Anthropometry, blood tests and energy expenditure are performed after the period of diet rich in carbohydrates (Carb), after the first 6 days (HFshort) and at the end of the period of diet rich in fat (HFlong).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Response to Dietary Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet interventions

Sequential dietary intervention

Group Type EXPERIMENTAL

Isocaloric high carbohydrate diet intervention

Intervention Type OTHER

Time of 6 week, the last 6 days are standardized

Isocaloric high fat diet intervention

Intervention Type OTHER

Time of 6 weeks; the first and the last 6 days are standardized

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Isocaloric high carbohydrate diet intervention

Time of 6 week, the last 6 days are standardized

Intervention Type OTHER

Isocaloric high fat diet intervention

Time of 6 weeks; the first and the last 6 days are standardized

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy twins
* BMI 18,5-35kg/m²
* BMI difference \< 3kg/m² within the pair of twins
* Stable weight during the last 3 months
* Willingness to comply with the assigned diets over the study period

Exclusion Criteria

* Consumptive diseases
* Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
* Diabetes type 1 and type 2
* Pregnancy
* Chronic disease of heart, kidney, liver
* High grade anaemia
* High grade infection disease
* Relevant change of body weight(+/- 2kg)during isoenergetic 12-weeks of dietary intervention
* Missing data about primary outcome measures (IVGTT, MTT, data about dietary intake from food diaries or food protocols)
* Significant deviation from dietary targets during the monitored 12 weeks isoenergetic period
* Allergies including food allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Ernst von Bergmann Hospital

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

HealthTwist GmbH, Berlin, Germany

UNKNOWN

Sponsor Role collaborator

Max-Planck Institute of Molecular Cell Biology and Genetics

OTHER

Sponsor Role collaborator

Helmholtz Center Munich

UNKNOWN

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. med. Andreas F. H. Pfeiffer

Chief, Department of Clinical Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas FH Pfeiffer, Prof

Role: PRINCIPAL_INVESTIGATOR

German Institute of Human Nutrition Potsdam-Rehbruecke

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Schuler R, Seebeck N, Osterhoff MA, Witte V, Floel A, Busjahn A, Jais A, Bruning JC, Frahnow T, Kabisch S, Pivovarova O, Hornemann S, Kruse M, Pfeiffer AFH. VEGF and GLUT1 are highly heritable, inversely correlated and affected by dietary fat intake: Consequences for cognitive function in humans. Mol Metab. 2018 May;11:129-136. doi: 10.1016/j.molmet.2018.02.004. Epub 2018 Feb 12.

Reference Type DERIVED
PMID: 29506909 (View on PubMed)

Schuler R, Osterhoff MA, Frahnow T, Seltmann AC, Busjahn A, Kabisch S, Xu L, Mosig AS, Spranger J, Mohlig M, Hornemann S, Kruse M, Pfeiffer AF. High-Saturated-Fat Diet Increases Circulating Angiotensin-Converting Enzyme, Which Is Enhanced by the rs4343 Polymorphism Defining Persons at Risk of Nutrient-Dependent Increases of Blood Pressure. J Am Heart Assoc. 2017 Jan 17;6(1):e004465. doi: 10.1161/JAHA.116.004465.

Reference Type DERIVED
PMID: 28096099 (View on PubMed)

Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.

Reference Type DERIVED
PMID: 25822100 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMBF NUGAT 0315424

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Precision Nutrition and Metabolic Function
NCT04131166 ACTIVE_NOT_RECRUITING NA