NCT01631123

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration 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

September 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

June 1, 2012

Last Update Submit

January 23, 2013

Conditions

Metabolic Response to Dietary Modification

Keywords

TwinsHigh carbohydrat dietHigh fat dietIsocaloricNutrigenomics

Outcome Measures

Primary Outcomes (1)

  • Genetic variance of change in insulin secretion and sensitivity after sequential diets

    change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT)

    6,7,12 weeks

Secondary Outcomes (10)

  • Variance of insulin sensitivity after the sequential diets

    6, 7, 12 weeks

  • Expression of inflammatory markers in blood and fat tissue

    6,7,12 weeks

  • Development of indices for the prediction of fat mass

    6,7,12 weeks

  • Changes in vessel wall thickness of the carotid artery

    6,7,12 weeks

  • Measurement of activity

    in the 6th, 7th, 12th week

  • +5 more secondary outcomes

Study Arms (1)

Diet interventions

EXPERIMENTAL

Sequential dietary intervention

Other: Isocaloric high carbohydrate diet interventionOther: Isocaloric high fat diet intervention

Interventions

Isocaloric high carbohydrate diet interventionOTHER

Time of 6 week, the last 6 days are standardized

Diet interventions
Isocaloric high fat diet interventionOTHER

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

Diet interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, 14558, Germany

Location

Related Publications (3)

  • 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.

    PMID: 29506909DERIVED

  • 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.

    PMID: 28096099DERIVED

  • 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.

    PMID: 25822100DERIVED

Study Officials

  • Andreas FH Pfeiffer, Prof

    German Institute of Human Nutrition Potsdam-Rehbruecke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Clinical Nutrition

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 28, 2012

Study Start

September 1, 2009

Primary Completion

January 1, 2010

Study Completion

September 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

DE(1)