NCT01320228

Brief Summary

The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake, anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium concentrate (Capolac) in addition to treatment with Alli ®:

  1. 1.Alli® (60 mg t.i.d) plus placebo (rice flour)
  2. 2.Alli® plus 5 g flaxseed fibers
  3. 3.Alli® plus 1200 mg Ca from Capolac
  4. 4.Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2011

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

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

March 21, 2011

Last Update Submit

September 1, 2014

Conditions

Obesity

Keywords

Obesityorlistatfat excretionfiberdairy calcium

Outcome Measures

Primary Outcomes (1)

  • Ratings of gastrointestinal comfort

    Subjective assessment of gastrointestinal comfort using visual analogue scales

    baseline, week 0, 2, 4, 8, 12

Secondary Outcomes (7)

  • Total fecal fat excretion

    week 0 and 4

  • Total, LDL and HDL cholesterol

    baseline and 12

  • Ratings of quality of life

    baseline, week 0, 2, 4, 8 and 12

  • Body weight

    baseline, week 0, 2, 4, 6, 8, 10 and 12

  • Waist and hip circumference

    Baseline, week 0, 2, 4, 6, 8, 10 and 12

  • +2 more secondary outcomes

Study Arms (4)

Control

PLACEBO COMPARATOR

Alli treatment plus placebo (rice flour)

Dietary Supplement: Control

Capolac

EXPERIMENTAL

Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)

Dietary Supplement: Capolac

Flax fiber

EXPERIMENTAL

Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)

Dietary Supplement: Flax fiber

Capolac+Flax fiber

EXPERIMENTAL

Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Dietary Supplement: Capolac+Flax fiber

Interventions

ControlDIETARY_SUPPLEMENT

Alli treatment plus placebo (rice flour)

Control
CapolacDIETARY_SUPPLEMENT

Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)

Capolac
Flax fiberDIETARY_SUPPLEMENT

Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)

Flax fiber
Capolac+Flax fiberDIETARY_SUPPLEMENT

Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Capolac+Flax fiber

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • men and women
  • BMI 30-40 kg/m2

You may not qualify if:

  • Dairy allergy and/or intolerance, allergy to Orlistat
  • Infectious and metabolic diseases
  • Gastrointestinal diseases (previous and current)
  • Troubles swallowing tablets and capsules
  • Dietary supplement use during the trial and 1 month prior to the trial
  • Postmenopausal (selfreported)
  • Pregnancy and lactation
  • Treatment with oral anticoagulation medications, ciclosporin, levothyroxin, antiepileptika, acarbose and amiodaron
  • Prescription medication will be considered on an individual basis at the screening visit according to SOP
  • Dieting or other changes of diet within 3 months
  • Participation in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • Kristensen M, Juul SR, Sorensen KV, Lorenzen JK, Astrup A. Supplementation with dairy calcium and/or flaxseed fibers in conjunction with orlistat augments fecal fat excretion without altering ratings of gastrointestinal comfort. Nutr Metab (Lond). 2017 Feb 7;14:13. doi: 10.1186/s12986-017-0164-8. eCollection 2017.

    PMID: 28191026DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Astrup, MD, Dr.med.

    Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer, Dr. Med.

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

DK(1)