Clinical Effects of Nutrition on Metabolic Risk Factors and Mechanisms

NCT02405806 | Completed

• 1 other identifier: 140917-281
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall aim for this study is to evaluate the clinical effects of a modified diet on metabolic risk factors such as diabetes mellitus and obesity, and the mechanisms this nutrition composition exerts on gastrointestinal physiology, inflammatory responses, and quality of life, where the subjects are their own controls. Within this study, the investigators will be able to relate the nutritional composition to metabolic disorders, the gut microbiota, secreted intestinal neuropeptides, and bio- and inflammatory markers in serum, plasma and urine.

Conditions

Obesity; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Change from baseline in metabolic effects, intestinal permeability and microbiota composition after food intervention

  In the larger study, the investigator will give the patients a moderate, low carbohydrate food for 3 months and then evaluate the effects in plasma concentration of insulin, fp-glucose, C-peptide, proinsulin, HbA1c, lipids, and zonulin. Feces wil be analyzed for microbiota composition as quantified by PCR.

  3 months

Secondary Outcomes (1)

• Quality of life as assessed by the SF-36

  3 months

Other Outcomes (1)

• Change from baseline in hormonal effects of food intervention

  3 hours

Study Arms (2)

low carbohydrate food

EXPERIMENTAL

The subjects will be given a diet with moderate, low carbohydrate content for 3 months, or as a single test meal, and this will be evaluated in metabolic parameters, microbiota and biomarkers in serum as described previously. Intervention: Food: Low carbohydrate food

Dietary Supplement: low carbohydrate food

standard food

ACTIVE COMPARATOR

The subjects will be given a diet with standard food as a single test meal, and this will be evaluated in metabolic parameters, microbiota and biomarkers in serum, as described Intervention: Food: Standard food

Dietary Supplement: standard food

Interventions

low carbohydrate food DIETARY_SUPPLEMENT

low carbohydrate food

low carbohydrate food

standard food DIETARY_SUPPLEMENT

standard food

standard food

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects should be healthy.
• Prediabetes should have fasting plasma glucose levels o 5.6-6.9 mmol/l or plasma glucose level 2 h after an oral glucose test of 7.8-11.1 mmol/l, without any diabetes treatment.
• Patients with diabetes should have type-2 diabetes.
• Obesity should have BMI 30-3 and glucose levels within reference values

You may not qualify if:

• Patients with diabetes or obesity should not have severe cardiac, kidney, liver or psychiatric diseases

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Related Publications (2)

• Ohlsson B, Bjorgell O, Ekberg O, Darwiche G. The oxytocin/vasopressin receptor antagonist atosiban delays the gastric emptying of a semisolid meal compared to saline in human. BMC Gastroenterol. 2006 Mar 16;6:11. doi: 10.1186/1471-230X-6-11.

  PMID: 16542457 BACKGROUND

• Sullivan M, Karlsson J, Taft C. SF-36: Swedish manual and interpretation guide, 2nd Edition. Gothenburg: Sahlgrenska University Hospital. 2002.

  BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bodil Ohlsson, Professor

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, senior consultant

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 1, 2015
• Study Start: November 1, 2014
• Primary Completion: October 15, 2015
• Study Completion: December 31, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01