NCT03295448

Brief Summary

The overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

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

First Submitted

Initial submission to the registry

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

October 25, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

September 22, 2017

Last Update Submit

November 14, 2018

Conditions

Keywords

fatty acidsbiomarkercarbohydratelipogenesis

Outcome Measures

Primary Outcomes (1)

  • Palmitic acid in different plasma fractions

    Measured by liquid gas chromatography (GC)

    14-20 days

Secondary Outcomes (1)

  • Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids

    14-20 days

Other Outcomes (1)

  • Desaturation indices end lipogenic indices

    14-20 days

Study Arms (6)

Fat - Sugar - Fiber

ACTIVE COMPARATOR

Intervention: consuming diets rich in fat, rich in sugar, and rich in fibers during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Fat - Fiber - Sugar

ACTIVE COMPARATOR

Intervention: consuming diets rich in fat, rich in fiber, and rich sugar during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Sugar - Fiber - Fat

ACTIVE COMPARATOR

Intervention: Consuming diets rich in sugar, rich in fiber, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Sugar - Fat - Fiber

ACTIVE COMPARATOR

Intervention: Consuming diets rich in sugar, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Fiber - Sugar - Fat

ACTIVE COMPARATOR

Intervention: Consuming diets rich in fiber, rich in sugar, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Fiber - Fat - Sugar

ACTIVE COMPARATOR

Intervention: consuming diets rich in fiber, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.

Other: Low carbohydrate dietOther: High carbohydrate, high sugar dietOther: High carbohydrate, low sugar diet

Interventions

Diet low in carbohydrates (38%E), but higher in total and saturated fat.

Fat - Fiber - SugarFat - Sugar - FiberFiber - Fat - SugarFiber - Sugar - FatSugar - Fat - FiberSugar - Fiber - Fat

Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.

Fat - Fiber - SugarFat - Sugar - FiberFiber - Fat - SugarFiber - Sugar - FatSugar - Fat - FiberSugar - Fiber - Fat

Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.

Fat - Fiber - SugarFat - Sugar - FiberFiber - Fat - SugarFiber - Sugar - FatSugar - Fat - FiberSugar - Fiber - Fat

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 20-38

You may not qualify if:

  • abnormal lab tests (assessed by screening and judged by a physician), diabetes, cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the preceding 3 months of screening. Extreme diets, i.e. very-low carbohydrate diets, intermittent fasting, vegan diets or allergic to gluten

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala univeristy hospital

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • Bajahzer MF, Rosqvist F, Friden M, Iggman D, Pingel R, Marklund M, Riserus U. Contrasting Carbohydrate Quantity and Quality and the Effects on Plasma Saturated and Monounsaturated Fatty Acids in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2023 Mar;153(3):683-690. doi: 10.1016/j.tjnut.2023.01.005. Epub 2023 Jan 13.

MeSH Terms

Conditions

Dyslipidemias

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ulf Riserus, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

October 25, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations