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Type 2 Diabetes MellitusNCT03421301

Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.

A study testing dietary portfolio in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.

Completed

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

Official record
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Trial summary

Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were enrolled in a double-blind, parallel-arm, placebo-control study were randomized to receive a dietary portfolio (DP) or placebo (P)… Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
dietary portfolio
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
7 Aug 2014to 28 Dec 2016
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • clinical diagnosis of type 2 diabetes
  • Male or female.
  • Adults between 30 and 60 years old.
  • BMI of 25 to 39.9 kg / m².
  • Pharmacological treatment with metformin, a combination of metformin and glibenclamide.
  • Evolution of the type 2 diabetes of 4 ± 3 years.
  • Patients who knew how to read and write.
  • Signature of informed consent.

Who cannot join

  • Diseases that produce secondary obesity.
  • Cardiovascular event.
  • Weight loss> 3 kg in the last 3 months after the evaluation of the criteria.
  • Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
  • Gravidity status.
  • Positive smoking.
Show all 18Show fewer
  • Treatment with antihypertensive drugs
  • Treatment with other hypoglycemic agents that were not metformin
  • Treatment with statins, fibrates or other drugs to control dyslipidemia, 6 months before the start of the protocol.
  • Any drug or medication that activates intestinal motility
  • Use of laxatives or antispasmodics 4 weeks before the study
  • Treatment with antibiotics 6 months before the study
  • Use of steroids, chemotherapy, immunosuppressant or radiotherapy.
  • Uncontrolled type 2 diabetes, ( HbA1c concentration ≥ 9.9%)
  • Fasting glucose ≥ 220 mg / dL
  • Fasting cholesterol ≥ 240 mg / dL
  • Fasting triglycerides ≥ 350 mg / dL
  • Serum creatinine in women> 1.2 mg / dL in men> 1.3 mg / d

About this study

Official title: A Dietary Intervention With Functional Foods Reduce Metabolic Endotoxemia and Attenuates Biochemical Abnormalities in Subjects With Type 2 Diabetes by Modifying the Gut Microbiota.

Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were enrolled in a double-blind, parallel-arm, placebo-control study were randomized to receive a dietary portfolio (DP) or placebo (P) treatment for 3 mo. The primary endpoint was the effect of a dietary portfolio based on functional foods on gut microbiota. Secondary endpoints were biochemical parameters, branched chain amino acids, TMAO

Read the detailed description

This study was a single-center, randomized, controlled, double-blind, parallel versus placebo that consisted of six visits. The first visit was a screening evaluation to determine whether subjects meet the inclusion criteria. The selected subjects were invited to a second visit that consisted of a medical history, 2-h oral glucose tolerance test (OGTT), collection of stool samples for DNA isolation and collection of 5 ml blood sample. The participants received the first stage dietary strategy for 15 days. In the third visit and second stage of dietary treatment, subjects were randomized to received the dietary portfolio (DP) or placebo (P) treatment accompanied of the reduced energy diet for 1 mo. In the fourth and fifth visits, with a 1 mo interval, dietary assessment and compliance to the DP or P was evaluated. During each follow-up visit, a 24-h dietary recall was collected, a physical activity questionnaire was filled out and anthropometric and clinical parameters were assessed. In the sixth visit, a 2-h oral glucose tolerance test (OGTT) was performed, and a stool sample for DNA isolation and 5 ml blood were collected.

Dietary Intervention In the first stage, the participants consumed a reduced-energy diet tailored to provide a 500-kcal/d deficit as recommended by NIH (8) the with respect to their habitual diet for 15 days. The diet plan consisted in 45-55% carbohydrates, 15-20% protein, 25-35% fat, <7% saturated fat, 200 mg/d cholesterol, 20-35g fiber, 2000-3000 mg/d sodium based on total energy. In the second stage the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (dietary portfolio; DP). The DP provided 200 kcal that were subtracted from the diet. The DP consisted of a mixture of 14g of dehydrated nopal, 4g of chia seed, 30g of soy protein, 4g of inulin,) and 1g of flavoring. The placebo (P) consisted of 28 g of calcium caseinate, 15g of maltodextrin and 1g of flavoring. The kcal, appearance and flavor were similar in DP and P. The DP and P was given in a package in dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 17.3 g of DP or P given in the breakfast and dissolved in 250 ml and the second package was given at the dinner time (15:00-16:00 h) and contained 34.7g of P and DP dissolved in 300 mL of water.

Dietary compliance Dietary compliance was assessed with a 24-h dietary recall and 3-d food record (food log), during each visit that were analyzed by Food Processor Nutrition Analysis Software. The compliance of the consumption of the DP or P was evaluated with the number of empty packages returned at the following visit. Physical activity was assessed using the International physical activity questionnaire (IPAQ).

Being tested
dietary portfolio
Keywords
gut microbiota, functional foods, branched chain amino acids, TMAO, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • dietary portfolioDietary supplement

    The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein and inulin) that was provided in dehydrated form in packages of 17.3 g dissolved in 250 ml water for breakfast and 34.7 g in 300 ml water for dinner.

Study groups in NCT03421301
Study groupRoleWhat they receive
1. Dietary portfolio (DP)Experimentalthe dietary portfolio was given daily in the breakfast and dinner for 2.5 months
Receives: Dietary Supplement: dietary portfolio
2. placebo (P)Placebo comparatorthe placebo (P) was based was given daily in the breakfast and dinner for 2.5 months
Receives: Dietary Supplement: dietary portfolio

What is being measured

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

  1. intestinal microbiota

    Measurement of intestinal microbiota by sequencing using the Illumina platform

    Measured: Change from baseline gut microbiota at three months after the dietary intervention

Secondary outcomes (14)

  1. Glucose metabolism profile

    serum glucose (mg/dl)

    Measured: Change from baseline serum glucose at three months after dietary intervention

  2. Glucose metabolism profile

    serum insulin (µUI/ml)

    Measured: Change from baseline serum insulin at three months after dietary intervention

  3. Glucose metabolism profile

    plasma glycated hemoglobin (HbA1c) (%)

    Measured: Change from baseline plasma HbA1c at three months after dietary intervention

  4. Lipid metabolism profile

    serum triglycerides (mg/dl)

    Measured: Change from baseline serum triglycerides at three months after dietary intervention

  5. Lipid metabolism profile

    serum total cholesterol (mg/dl)

    Measured: Change from baseline serum total cholesterol at three months after dietary intervention

  6. Lipid metabolism profile

    serum LDL cholesterol (mg/dl)

    Measured: Change from baseline serum LDL cholesterol at three months after dietary intervention

  7. Lipid metabolism profile

    serum HDL cholesterol (mg/dl)

    Measured: Change from baseline serum HDL cholesterol at three months after dietary intervention

  8. Lipid metabolism profile

    plasma free fatty acids (FFA) (mmol/L)

    Measured: Change from baseline plasma free fatty acids at three months after dietary intervention

  9. metabolomic profile

    plasma betaine (µmol/L)

    Measured: Change from baseline plasma betaine at three months after dietary intervention

  10. metabolomic profile

    plasma choline (µmol/L)

    Measured: Change from baseline plasma choline at three months after dietary intervention

  11. metabolomic profile

    plasma trimethylamine oxide (TMAO) (µmol/L)

    Measured: Change from baseline plasma TMAO at three months after dietary intervention

  12. metabolomic profile

    plasma branched chain amino acids (BCAA) (µmol/L)

    Measured: Change from baseline plasma BCAA at three months after dietary intervention

  13. inflammatory profile

    plasma lipopolysaccharide (LPS) (ng/ml)

    Measured: Change from baseline plasma LPS at three months after dietary intervention

  14. inflammatory profile

    serum C reactive protein (CRP) (mg/dl)

    Measured: Change from baseline serum CRP at three months after dietary intervention

Timeline

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

  1. First posted5 Feb 2018
  2. Study start7 Aug 2014
  3. Primary completion28 Sep 2016
  4. Study completion28 Dec 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In the first stage, the participants with type 2 diabetes consumed a reduced-energy diet tailored to provide a 500-kcal/d deficit as recommended by NIH (8) the with respect to their habitual diet for 15 days. In the second stage the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (dietary portfolio; DP). The DP provided 200 kcal that were subtracted from the diet. The DP consisted of a mi The kcal, appearance and flavor were similar in DP and P. The DP and P was given in a package in dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 17.3 g of DP or P given in the breakfast and dissolved in 250 ml and the second package was given at the dinner time (15:00-16:00 h) and contained 34.7g of P and DP dissolved in 300 mL of water.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03421301
Sponsor's protocol ID
1165
Status last verified
Jan 2018
First submitted
17 Jan 2018
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519

  • Mahendran Y, Cederberg H, Vangipurapu J, Kangas AJ, Soininen P, Kuusisto J, Uusitupa M, Ala-Korpela M, Laakso M. Glycerol and fatty acids in serum predict the development of hyperglycemia and type 2 diabetes in Finnish men. Diabetes Care. 2013 Nov;36(11):3732-8. doi: 10.2337/dc13-0800. Epub 2013 Sep 11.

    PubMed 24026559

  • Evans JL, Goldfine ID, Maddux BA, Grodsky GM. Are oxidative stress-activated signaling pathways mediators of insulin resistance and beta-cell dysfunction? Diabetes. 2003 Jan;52(1):1-8. doi: 10.2337/diabetes.52.1.1.

    PubMed 12502486

  • Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-85. doi: 10.1038/nm.3145. Epub 2013 Apr 7.

    PubMed 23563705

  • Griffin JL, Wang X, Stanley E. Does our gut microbiome predict cardiovascular risk? A review of the evidence from metabolomics. Circ Cardiovasc Genet. 2015 Feb;8(1):187-91. doi: 10.1161/CIRCGENETICS.114.000219.

    PubMed 25691688

  • Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.

    PubMed 27409811

  • Serralde-Zuniga AE, Guevara-Cruz M, Tovar AR, Herrera-Hernandez MF, Noriega LG, Granados O, Torres N. Omental adipose tissue gene expression, gene variants, branched-chain amino acids, and their relationship with metabolic syndrome and insulin resistance in humans. Genes Nutr. 2014 Nov;9(6):431. doi: 10.1007/s12263-014-0431-5. Epub 2014 Sep 27.

    PubMed 25260659

  • Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.

    PubMed 9813653

  • Sanchez-Tapia M, Aguilar-Lopez M, Perez-Cruz C, Pichardo-Ontiveros E, Wang M, Donovan SM, Tovar AR, Torres N. Nopal (Opuntia ficus indica) protects from metabolic endotoxemia by modifying gut microbiota in obese rats fed high fat/sucrose diet. Sci Rep. 2017 Jul 5;7(1):4716. doi: 10.1038/s41598-017-05096-4.

    PubMed 28680065

  • Segata N, Izard J, Waldron L, Gevers D, Miropolsky L, Garrett WS, Huttenhower C. Metagenomic biomarker discovery and explanation. Genome Biol. 2011 Jun 24;12(6):R60. doi: 10.1186/gb-2011-12-6-r60.

    PubMed 21702898

  • Forslund K, Hildebrand F, Nielsen T, Falony G, Le Chatelier E, Sunagawa S, Prifti E, Vieira-Silva S, Gudmundsdottir V, Pedersen HK, Arumugam M, Kristiansen K, Voigt AY, Vestergaard H, Hercog R, Costea PI, Kultima JR, Li J, Jorgensen T, Levenez F, Dore J; MetaHIT consortium; Nielsen HB, Brunak S, Raes J, Hansen T, Wang J, Ehrlich SD, Bork P, Pedersen O. Disentangling type 2 diabetes and metformin treatment signatures in the human gut microbiota. Nature. 2015 Dec 10;528(7581):262-266. doi: 10.1038/nature15766. Epub 2015 Dec 2.

    PubMed 26633628

  • van der Hulst RR, van Kreel BK, von Meyenfeldt MF, Brummer RJ, Arends JW, Deutz NE, Soeters PB. Glutamine and the preservation of gut integrity. Lancet. 1993 May 29;341(8857):1363-5. doi: 10.1016/0140-6736(93)90939-e.

    PubMed 8098788

  • Achamrah N, Dechelotte P, Coeffier M. Glutamine and the regulation of intestinal permeability: from bench to bedside. Curr Opin Clin Nutr Metab Care. 2017 Jan;20(1):86-91. doi: 10.1097/MCO.0000000000000339.

    PubMed 27749689

  • Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.

    PubMed 22517736

  • Gomes AC, Bueno AA, de Souza RG, Mota JF. Gut microbiota, probiotics and diabetes. Nutr J. 2014 Jun 17;13:60. doi: 10.1186/1475-2891-13-60.

    PubMed 24939063

Questions about this trial

What is this clinical trial studying?

A study testing dietary portfolio in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.

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 8 inclusion and 18 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 5 Feb 2018. 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?

intestinal microbiota (time frame: Change from baseline gut microbiota at three months after the dietary intervention). 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 NCT03421301, which also lists 25 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 5 Feb 2018.

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