Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.

NCT ID: NCT02770833

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-01-31

Brief Summary

The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety. The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Salmon vs. veal and CHO with low or high GI

In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:

• Meat balls with salmon served with tomato sauce and other accompaniments with low GI
• Meat balls with salmon served with tomato sauce and other accompaniments with high GI
• Meat balls with veal served with tomato sauce and other accompaniments with low GI
• Meat balls with veal served with tomato sauce and other accompaniments with high GI

Group Type: EXPERIMENTAL

Fish and carbohydrats with low or high GI

Intervention Type: OTHER

Veal and carbohydrats with low or high GI

Intervention Type: OTHER

Cod vs. veal and CHO with low or high GI

In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:

• Meat balls with codfish served with tomato sauce and other accompaniments with low GI
• Meat balls with codfish served with tomato sauce and other accompaniments with high GI
• Meat balls with veal served with tomato sauce and other accompaniments with low GI
• Meat balls with veal served with tomato sauce and other accompaniments with high GI

Group Type: EXPERIMENTAL

Fish and carbohydrats with low or high GI

Intervention Type: OTHER

Veal and carbohydrats with low or high GI

Intervention Type: OTHER

Interventions

Fish and carbohydrats with low or high GI

Intervention Type: OTHER

Veal and carbohydrats with low or high GI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women
• Between 18 and 50 years of age
• BMI between 25.0 and 30.0 kg×m-2
• Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit)
• Non-smoker

Exclusion Criteria

• Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
• Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
• Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
• Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
• Menopausal women and women with an irregular menstrual cycle
• Food allergies
• Substance abuse
• Vigorous physical activity more than 10 hours/week
• Alcohol intake above the recommendations from the Danish Health and Medicines Authority
• Caffeine intake above 300 mg/day
• Night- or shift work
• Blood donation <1 month before study commencement and during study period
• Simultaneous participation in other clinical studies
• Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
• Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Fisheries and Aquaculture Industry Research Fund

OTHER

Sponsor Role: collaborator

National Institute of Nutrition and Seafood Research, Norway

OTHER_GOV

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Anne Birgitte Raben

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Raben, Prof

Role: PRINCIPAL_INVESTIGATOR

Prof at the department of Nutrition, Exercise and Sports

Locations

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, Denmark

Countries

Denmark

Other Identifiers

H-1-2014-038 (B314)

Identifier Type: -

Identifier Source: org_study_id