Fructose and Ethnic Differences Study (FED Study)

NCT02533817 | Completed

• 1 other identifier: BDM/12/13-7
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the UK, people of black West African and Caribbean's tend to have healthier blood cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack. But rates of heart disease are now rising in young African-American populations with diabetes, for the first time exceeding the rate in their white European-American peers. One possible culprit is the increasing consumption of fructose which can lead to high blood fat levels. Fructose is a natural sugar found in fruits and table sugar but is also used the food industry as an ingredient and sweetener. Because fructose intakes are lower in the UK than in North America we are studying the effect of fructose intake in UK black West African and Caribbean people, to understand if fructose intake is indeed a reason for these ethnic differences.

Conditions

Healthy

Keywords

Fructose; Insulin; Postprandial lipemia; Ambulatory blood pressure; Ethnicity

Outcome Measures

Primary Outcomes (1)

• Postprandial triglyceride concentrations

  At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample. A final blood sample was drawn at 24 hours under fasting conditions.

  0-420 minutes

Secondary Outcomes (5)

• Postprandial glucose concentrations.

  0-420 minutes

• Serum and red blood cell cholesterol and non-cholesterol sterol concentrations

  0 and 24-hour post treatment

• Postprandial insulin concentrations

  0-420 minutes

• Postprandial c-peptide concentrations

  0-420 minutes

• Postprandial non-esterified fatty acid concentrations

  0-420 minutes

Other Outcomes (2)

• Ambulatory blood pressure

  Blood pressure was measured every 20 minutes during the postprandial period.

• Serum uric acid concentrations

  Serum uric acid concentrations measured at 0, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes.

Study Arms (2)

Dietary Sugar - Fructose

EXPERIMENTAL

Each participant consumed 20% daily caloric requirement as fructose.

Dietary Supplement: Dietary sugar

Dietary Sugar - Glucose

ACTIVE COMPARATOR

Each participant consumed 20% daily caloric requirement as glucose.

Dietary Supplement: Dietary sugar

Interventions

Dietary sugar DIETARY_SUPPLEMENT

This study examined the effect of high intakes of fructose compared to high intakes of glucose in a randomized crossover design. The treatment was in replacement of 20% of the daily caloric requirements for either fructose or glucose for each individual.

Dietary Sugar - Fructose; Dietary Sugar - Glucose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported healthy, confirmed by blood tests (i.e. liver enzymes, full blood count, lipids, glucose); ethnicity White European participants had at least 3 grandparents originating from countries of Europe and Black African participants had at least 3 grandparents originating primarily from countries of West Africa (Economic Community of West African States (ECOWAS) and central African countries (e.g. Cameroon, Uganda, etc).

You may not qualify if:

• fasting glucose in the diabetic range (fasting glucose \>7 mmol/l); hypertension (medically diagnosed or \>140/90 mm Hg at screening); hyperlipidaemia deemed to require immediate medical intervention (defined as: total cholesterol \>6.0 mmol/l; LDL-cholesterol \>4.5 mmol/l; fasting TG \>3 mmol/l).

Sponsors & Collaborators

• King's College London: lead

Related Publications (1)

• Goff LM, Whyte MB, Samuel M, Harding SV. Significantly greater triglyceridemia in Black African compared to White European men following high added fructose and glucose feeding: a randomized crossover trial. Lipids Health Dis. 2016 Sep 2;15(1):145. doi: 10.1186/s12944-016-0315-3.

  PMID: 27590876 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dietary Sugars

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Sugars; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Scott V Harding, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 27, 2015
• Study Start: December 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05