Diabetes-specific formula with standard of care improves glycemic control, body composition, and cardiometabolic risk factors in overweight and obese adults with type 2 diabetes: results from a randomized controlled trial
Medical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D). Participants ( = 235) were randomized to either D...
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| Published in | Frontiers in nutrition (Lausanne) Vol. 11; p. 1400580 |
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| Main Authors | , , , , , , , , |
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| Language | English |
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15.07.2024
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| Abstract | Medical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D).
Participants (
= 235) were randomized to either DSF with standard of care (SOC) (DSF group;
= 117) or SOC only (control group;
= 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90.
There were significant reductions in glycated hemoglobin (-0.44% vs. -0.26%,
0.015, at day 45; -0.50% vs. -0.21%,
0.002, at day 90) and fasting blood glucose (-0.14 mmol/L vs. +0.32 mmol/L,
0.036, at day 90), as well as twofold greater weight loss (-1.30 kg vs. -0.61 kg,
< 0.001, at day 45; -1.74 kg vs. -0.76 kg,
< 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%,
0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (-6.52% vs. -0.95%,
< 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall
≤ 0.045).
DSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D. |
|---|---|
| AbstractList | Background and aimsMedical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D).MethodsParticipants (n = 235) were randomized to either DSF with standard of care (SOC) (DSF group; n = 117) or SOC only (control group; n = 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90.ResultsThere were significant reductions in glycated hemoglobin (−0.44% vs. –0.26%, p = 0.015, at day 45; −0.50% vs. −0.21%, p = 0.002, at day 90) and fasting blood glucose (−0.14 mmol/L vs. +0.32 mmol/L, p = 0.036, at day 90), as well as twofold greater weight loss (−1.30 kg vs. –0.61 kg, p < 0.001, at day 45; −1.74 kg vs. –0.76 kg, p < 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%, p = 0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (−6.52% vs. –0.95%, p < 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall p ≤ 0.045).ConclusionDSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D. Medical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D).Background and aimsMedical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D).Participants (n = 235) were randomized to either DSF with standard of care (SOC) (DSF group; n = 117) or SOC only (control group; n = 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90.MethodsParticipants (n = 235) were randomized to either DSF with standard of care (SOC) (DSF group; n = 117) or SOC only (control group; n = 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90.There were significant reductions in glycated hemoglobin (-0.44% vs. -0.26%, p = 0.015, at day 45; -0.50% vs. -0.21%, p = 0.002, at day 90) and fasting blood glucose (-0.14 mmol/L vs. +0.32 mmol/L, p = 0.036, at day 90), as well as twofold greater weight loss (-1.30 kg vs. -0.61 kg, p < 0.001, at day 45; -1.74 kg vs. -0.76 kg, p < 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%, p = 0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (-6.52% vs. -0.95%, p < 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall p ≤ 0.045).ResultsThere were significant reductions in glycated hemoglobin (-0.44% vs. -0.26%, p = 0.015, at day 45; -0.50% vs. -0.21%, p = 0.002, at day 90) and fasting blood glucose (-0.14 mmol/L vs. +0.32 mmol/L, p = 0.036, at day 90), as well as twofold greater weight loss (-1.30 kg vs. -0.61 kg, p < 0.001, at day 45; -1.74 kg vs. -0.76 kg, p < 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%, p = 0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (-6.52% vs. -0.95%, p < 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall p ≤ 0.045).DSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D.ConclusionDSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D. Background and aims Medical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D). Methods Participants ( n = 235) were randomized to either DSF with standard of care (SOC) (DSF group; n = 117) or SOC only (control group; n = 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90. Results There were significant reductions in glycated hemoglobin (−0.44% vs. –0.26%, p = 0.015, at day 45; −0.50% vs. −0.21%, p = 0.002, at day 90) and fasting blood glucose (−0.14 mmol/L vs. +0.32 mmol/L, p = 0.036, at day 90), as well as twofold greater weight loss (−1.30 kg vs. –0.61 kg, p < 0.001, at day 45; −1.74 kg vs. –0.76 kg, p < 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%, p = 0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (−6.52% vs. –0.95%, p < 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall p ≤ 0.045). Conclusion DSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D. Medical nutrition therapy is important for diabetes management. This randomized controlled trial investigated the effects of a diabetes-specific formula (DSF) on glycemic control and cardiometabolic risk factors in adults with type 2 diabetes (T2D). Participants ( = 235) were randomized to either DSF with standard of care (SOC) (DSF group; = 117) or SOC only (control group; = 118). The DSF group consumed one or two DSF servings daily as meal replacement or partial meal replacement. The assessments were done at baseline, on day 45, and on day 90. There were significant reductions in glycated hemoglobin (-0.44% vs. -0.26%, 0.015, at day 45; -0.50% vs. -0.21%, 0.002, at day 90) and fasting blood glucose (-0.14 mmol/L vs. +0.32 mmol/L, 0.036, at day 90), as well as twofold greater weight loss (-1.30 kg vs. -0.61 kg, < 0.001, at day 45; -1.74 kg vs. -0.76 kg, < 0.001, at day 90) in the DSF group compared with the control group. The decrease in percent body fat and increase in percent fat-free mass at day 90 in the DSF group were almost twice that of the control group (1.44% vs. 0.79%, 0.047). In addition, the percent change in visceral adipose tissue at day 90 in the DSF group was several-fold lower than in the control group (-6.52% vs. -0.95%, < 0.001). The DSF group also showed smaller waist and hip circumferences, and lower diastolic blood pressure than the control group (all overall ≤ 0.045). DSF with SOC yielded significantly greater improvements than only SOC in glycemic control, body composition, and cardiometabolic risk factors in adults with T2D. |
| Author | Berde, Yatin Wakefield, Brittany Boonyavarakul, Apussanee Tey, Siew Ling Baggs, Geraldine Huynh, Dieu Thi Thu Lim, Lee-Ling Deerochanawong, Chaicharn Chee, Winnie S S |
| AuthorAffiliation | 1 Abbott Nutrition Research and Development, Asia-Pacific Centre , Singapore , Singapore 5 Department of Medicine, University of Malaya , Kuala Lumpur , Malaysia 7 Abbott Nutrition Research and Development , Columbus, OH , United States 4 Biostatistics and Statistical Programming, Cognizant Technology Solutions , Mumbai , India 3 Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University , Bangkok , Thailand 6 Department of Medicine, Phramongkutklao Hospital , Bangkok , Thailand 2 Department of Nutrition and Dietetics, International Medical University , Kuala Lumpur , Malaysia |
| AuthorAffiliation_xml | – name: 6 Department of Medicine, Phramongkutklao Hospital , Bangkok , Thailand – name: 1 Abbott Nutrition Research and Development, Asia-Pacific Centre , Singapore , Singapore – name: 7 Abbott Nutrition Research and Development , Columbus, OH , United States – name: 4 Biostatistics and Statistical Programming, Cognizant Technology Solutions , Mumbai , India – name: 2 Department of Nutrition and Dietetics, International Medical University , Kuala Lumpur , Malaysia – name: 5 Department of Medicine, University of Malaya , Kuala Lumpur , Malaysia – name: 3 Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University , Bangkok , Thailand |
| Author_xml | – sequence: 1 givenname: Siew Ling surname: Tey fullname: Tey, Siew Ling organization: Abbott Nutrition Research and Development, Asia-Pacific Centre, Singapore, Singapore – sequence: 2 givenname: Winnie S S surname: Chee fullname: Chee, Winnie S S organization: Department of Nutrition and Dietetics, International Medical University, Kuala Lumpur, Malaysia – sequence: 3 givenname: Chaicharn surname: Deerochanawong fullname: Deerochanawong, Chaicharn organization: Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand – sequence: 4 givenname: Yatin surname: Berde fullname: Berde, Yatin organization: Biostatistics and Statistical Programming, Cognizant Technology Solutions, Mumbai, India – sequence: 5 givenname: Lee-Ling surname: Lim fullname: Lim, Lee-Ling organization: Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia – sequence: 6 givenname: Apussanee surname: Boonyavarakul fullname: Boonyavarakul, Apussanee organization: Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand – sequence: 7 givenname: Brittany surname: Wakefield fullname: Wakefield, Brittany organization: Abbott Nutrition Research and Development, Columbus, OH, United States – sequence: 8 givenname: Geraldine surname: Baggs fullname: Baggs, Geraldine organization: Abbott Nutrition Research and Development, Columbus, OH, United States – sequence: 9 givenname: Dieu Thi Thu surname: Huynh fullname: Huynh, Dieu Thi Thu organization: Abbott Nutrition Research and Development, Asia-Pacific Centre, Singapore, Singapore |
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| Keywords | cardiometabolic risk factors body composition diabetes-specific formula type 2 diabetes glycemic control meal replacement nutrition therapy |
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| SubjectTerms | body composition diabetes-specific formula glycemic control meal replacement Nutrition nutrition therapy type 2 diabetes |
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| Title | Diabetes-specific formula with standard of care improves glycemic control, body composition, and cardiometabolic risk factors in overweight and obese adults with type 2 diabetes: results from a randomized controlled trial |
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