NCT01992783

Brief Summary

The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below 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

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

November 5, 2013

Last Update Submit

August 14, 2015

Conditions

OverweightObesity

Keywords

Resistant StarchAntioxidant StatusInsulin ResistanceOverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Antioxidant status

    Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)

    4 weeks

Secondary Outcomes (4)

  • Insulin resistance

    4 weeks

  • Lipid profile

    4 weeks

  • Blood pressure

    4 weeks

  • Anthropometric parameters

    4 weeks

Study Arms (2)

Hi-maize resistant starch

EXPERIMENTAL

13.5 g/day

Dietary Supplement: Hi-maize resistant starch

Maltodextrin

PLACEBO COMPARATOR

13.5 g/day

Dietary Supplement: Maltodextrin

Interventions

Hi-maize resistant starchDIETARY_SUPPLEMENT

13.5 g/day

Hi-maize resistant starch
MaltodextrinDIETARY_SUPPLEMENT

13.5 g/day

Maltodextrin

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight and obese adults
  • Age: 20-50 years

You may not qualify if:

  • weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month
  • pregnancy, lactation or menopause
  • History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease
  • Gastrointestinal disease of which ingredients found in the study products have adverse effects on that
  • Use of antihypertensive, lipid lowering or glucose lowering medications
  • Taking antioxidant, vitamin, and/or mineral supplements
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Urmia, Azerbaijan-gharbi, Iran

Location

Related Publications (1)

  • Eshghi F, Bakhshimoghaddam F, Rasmi Y, Alizadeh M. Effects of Resistant Starch Supplementation on Glucose Metabolism, Lipid Profile, Lipid Peroxidation Marker, and Oxidative Stress in Overweight and Obese Adults: Randomized, Double-Blind, Crossover Trial. Clin Nutr Res. 2019 Oct 28;8(4):318-328. doi: 10.7762/cnr.2019.8.4.318. eCollection 2019 Oct.

    PMID: 31720257DERIVED

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Interventions

high-amylose maize type 2 resistant starch, maizemaltodextrin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Mohammad Alizadeh, PhD

    Assistant Professor in Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 25, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

IR(1)