AzTrials
AzTrials

Insulin ResistanceNCT03146286

Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions

A study testing Saturated fat and Fish Oil in people with Insulin Resistance, run by University of Nottingham.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study will investigate whether impairment in the action of insulin to promote the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new protein in response to dietary protein… Read more about this study

Who is it for?
Ages 40 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Saturated fat and Fish Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
No sites listed yet
Study dates
1 Aug 2015to 3 Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male, healthy, overweight (BMI>27 kg/m2 and fat mass >30%) non-diabetic individuals.

Who cannot join

  • Diabetes, smoking, cardiovascular disease

About this study

The aim of the study will investigate whether impairment in the action of insulin to promote the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new protein in response to dietary protein intake, which ultimately may compromise maintenance of muscle size and quality of life and whether partially replacing saturated fat in the liquid meal with omega 3 polyunsaturated FA (n3PUFA) will ameliorate these negative effects.

Being tested
Saturated fat, Placebo, Fish Oil
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saturated fatDietary supplement

    Palm stearin

  • PlaceboDietary supplement

    Water

  • Fish OilDietary supplement

    Fish Oil, Omega 3 PUFA

Study groups in NCT03146286
Study groupRoleWhat they receive
ControlPlacebo comparatorChocolate flavoured drink spiked with 15mg/kg [2H31]palmitate (D31palmitate) and singly-labelled water (H218O). 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with [13C]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Receives: Dietary Supplement: Placebo
Saturated FatExperimentalChocolate flavoured drink spiked with 15mg/kg [2H31]palmitate (D31palmitate) and singly-labelled water (H218O) containing 0.7 g/kg bodyweight palm stearin. 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with [13C]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Receives: Dietary Supplement: Saturated fat
Fish OilExperimentalChocolate flavoured drink spiked with 15mg/kg [2H31]palmitate (D31palmitate) and singly-labelled water (H218O) containing 0.45 g/kg bodyweight palm stearin and 0.25 g/kg bodyweight fish oil (n3PUFA). 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with [13C]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Receives: Dietary Supplement: Fish Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in muscle protein fractional synthetic rate

    Measurement of FSR at baseline and post intervention

    Measured: 3 hours post protein drink

Secondary outcomes (2)

  1. whole body postprandial insulin sensitivity

    Glucose and insulin area under the curves (AUC) in response to the milk protein and glucose ingestion will be measured

    Measured: Baseline and every 15mins for 7 hours

  2. Whole body and skeletal muscle fat oxidation

    D31palmitate plasma enrichment and incorporation into skeletal muscle lipids

    Measured: Baseline and every 15mins for 7 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start1 Aug 2015
  3. Primary completion3 Dec 2015
  4. Study completion3 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03146286
Sponsor's protocol ID
SCA/OF/12/15
Status last verified
May 2019
First submitted
5 May 2017
Last updated
21 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.

    PubMed 22338035

  • Newens KJ, Thompson AK, Jackson KG, Wright J, Williams CM. DHA-rich fish oil reverses the detrimental effects of saturated fatty acids on postprandial vascular reactivity. Am J Clin Nutr. 2011 Sep;94(3):742-8. doi: 10.3945/ajcn.110.009233. Epub 2011 Aug 10.

    PubMed 21831993

  • Nowotny B, Zahiragic L, Krog D, Nowotny PJ, Herder C, Carstensen M, Yoshimura T, Szendroedi J, Phielix E, Schadewaldt P, Schloot NC, Shulman GI, Roden M. Mechanisms underlying the onset of oral lipid-induced skeletal muscle insulin resistance in humans. Diabetes. 2013 Jul;62(7):2240-8. doi: 10.2337/db12-1179. Epub 2013 Mar 1.

    PubMed 23454694

  • Wilhelmsen A, Davies A, Mallinson J, Pabla P, Jones R, Palmer EA, Dunn WB, Moran GW, Stephens FB, Tsintzas K. Acute effects of prior dietary fat ingestion on postprandial metabolic responses to protein and carbohydrate co-ingestion in overweight and obese men: A randomised crossover trial. Clin Nutr. 2022 Aug;41(8):1623-1635. doi: 10.1016/j.clnu.2022.06.022. Epub 2022 Jun 16.

    PubMed 35764009

Questions about this trial

What is this clinical trial studying?

A study testing Saturated fat and Fish Oil in people with Insulin Resistance, run by University of Nottingham.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle protein fractional synthetic rate (time frame: 3 hours post protein drink). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03146286, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in